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FDA Class II Recall: Sun Pharma's Mesalamine Extended-Release Capsules Face Nationwide Distribution Halt Over Dissolution Failure

MK
Meera KrishnanView Profile →
Senior Regulatory Intelligence Analyst
EXECUTIVE SUMMARY

Sun Pharmaceutical Industries Inc. has initiated a Class II recall for 54,960 bottles of Mesalamine Extended-Release Capsules, USP 500mg, due to failed dissolution specifications. This nationwide U.S. distribution halt, stemming from manufacturing in Mohali, India, necessitates immediate supply chain and procurement reassessment for this critical aminosalicylate, impacting patient access and regulatory compliance.

FDA Class II Recall: Sun Pharma's Mesalamine Extended-Release Capsules Fail Dissolution Specifications

Sun Pharmaceutical Industries Inc. has initiated a Class II voluntary recall, D-0350-2024, for multiple lots of its Mesalamine Extended-Release Capsules, USP 500mg. This critical action, commenced on February 5, 2024, and classified by the FDA on February 23, 2024, targets 54,960 bottles distributed nationwide across the U.S. The primary reason for this recall is a failure to meet dissolution specifications, indicating that the active pharmaceutical ingredient, Mesalamine, may not be released from the capsule at the intended rate or extent. For procurement directors and supply chain VPs, this means an immediate need to quarantine and return affected product, specifically lots MHD0606A, MHD0612A (Exp. 04/30/2024); MHD0613A, MHD0652A, MHD0657A, MHD0672A, MHD0673A (Exp. 05/31/2024); MHD0767A, MHD0768A, MHD0769A, MHD0785A, MHD0799A, MHD0800A, MHD0801A (Exp. 06/30/2024); MHD0827A, MHD0828A, MHD0875A, MHD0876A, MHD0898A, MHD0901A (Exp. 07/31/2024); and MHD1081A, MHD1082A, MHD1087A (Exp. 09/30/2024). The failure of dissolution directly impacts the drug's bioavailability and therapeutic effect, posing a risk to patients relying on consistent drug release for conditions such as ulcerative colitis. Regulatory affairs heads must ensure their organizations are fully compliant with recall procedures and assess the potential for increased scrutiny on future product batches from this manufacturer.

Manufacturing Origin and Therapeutic Impact of Mesalamine

The recalled Mesalamine Extended-Release Capsules, USP 500mg (ANDA214585, NDC 63304-089-13), were manufactured by Sun Pharmaceutical Industries Limited in Mohali, India, and distributed by its U.S. entity, Sun Pharmaceutical Industries, Inc., from Cranbury, NJ. Mesalamine, classified as an aminosalicylate, is a crucial human prescription drug administered orally for the treatment of inflammatory bowel diseases, primarily ulcerative colitis. Its extended-release formulation is designed to deliver the active substance consistently over time to specific areas of the gastrointestinal tract. A failure in dissolution specifications means the drug may not be released as intended, potentially leading to sub-therapeutic levels of Mesalamine in the patient's system. For business development executives, this highlights the critical importance of robust quality control at manufacturing sites, especially those in global supply chains. A compromised product efficacy can lead to adverse patient outcomes, erode physician trust, and result in significant market share loss. Procurement directors must scrutinize the quality assurance processes of their offshore manufacturing partners, as issues originating abroad can have immediate and severe repercussions on U.S. market access and patient care.

Supply Chain Risk: Nationwide Distribution of Affected Mesalamine Lots

The nationwide distribution of 54,960 bottles of Mesalamine Extended-Release Capsules across the U.S. amplifies the supply chain implications of this Class II recall. For supply chain VPs, this volume represents a substantial disruption, requiring immediate action to identify and halt the distribution of affected lots. The recall's 'Ongoing' status indicates that the full extent of product retrieval and market impact is still unfolding. Businesses relying on Sun Pharmaceutical Industries Inc. as a primary or secondary supplier for Mesalamine must activate contingency plans to prevent stockouts and ensure continuity of patient care. This includes identifying alternative sources, assessing their qualification status, and understanding lead times for new supply. The financial implications extend beyond the cost of returned goods, encompassing potential lost sales, increased administrative burden for recall management, and damage to brand reputation. Furthermore, the incident underscores the vulnerability of single-source or concentrated supply chains, emphasizing the strategic imperative for diversification to mitigate risks associated with quality failures at any point in the manufacturing and distribution network.

Broader Industry Context: Persistent Quality Control Challenges in Pharma

This Class II recall of Mesalamine Extended-Release Capsules by Sun Pharmaceutical Industries Inc. occurs within a broader landscape of persistent quality control challenges facing the pharmaceutical industry. Recent parallel events, such as Pfizer's Class I recalls for Bleomycin Injection and Sodium Bicarbonate Injection due to glass particulate matter, and Sandoz's Class II recall of Enoxaparin Sodium for temperature excursion risks, underscore a systemic vulnerability in pharmaceutical manufacturing and distribution. While the specifics differ, these incidents collectively highlight the critical importance of Current Good Manufacturing Practices (CGMP) and robust quality management systems. For regulatory affairs heads, these recurring events signal an environment of heightened FDA scrutiny, particularly concerning product quality attributes like dissolution, sterility, and stability. Business development executives must recognize that a strong compliance record is not merely a regulatory obligation but a significant competitive advantage, influencing market access and partnership opportunities. Companies with a history of quality issues, even if not directly linked to specific prior actions for Sun Pharmaceutical in this context, face increased pressure to demonstrate comprehensive remediation and preventative measures to maintain market trust and regulatory approval.

Regulatory Response and Commercial Implications for Sun Pharmaceutical

With the recall of Mesalamine Extended-Release Capsules classified as Class II and its status 'Ongoing,' Sun Pharmaceutical Industries Inc. faces significant commercial and regulatory implications. A Class II recall signifies that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. For Sun Pharmaceutical, this mandates a thorough investigation into the root cause of the failed dissolution specifications at its Mohali, India, manufacturing facility. Regulatory affairs teams must prepare for potential FDA inspections and be ready to submit comprehensive corrective and preventive action (CAPA) plans. Failure to adequately address the underlying quality issues could lead to further regulatory actions, including additional recalls, warning letters, or even import alerts for products manufactured at the Mohali site. Procurement directors should factor this increased regulatory risk into their supplier evaluations, as ongoing quality issues can disrupt long-term supply agreements. Business development executives need to assess the potential impact on future product approvals and market expansion, as a tarnished quality record can impede new drug applications and partnerships. The company's ability to swiftly and effectively remediate this issue will be crucial in mitigating long-term commercial damage and restoring confidence among healthcare providers and patients.

ChemLifeIntel analysis · Meera Krishnan. Compiled from primary and reported sources.
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REGULATORY INTELLIGENCE
2025-12-24

Novocol Pharmaceutical's OraVerse Recall: Phentolamine Mesylate Supply at Risk Due to Defective Cartridges

Novocol Pharmaceutical of Canada, Inc. has initiated a Class II recall for 1,636 cartons of OraVerse (Phentolamine Mesylate) Injection due to defective, cracked cartridges. This voluntary, nationwide U.S. recall, impacting lot D05004E, signals critical quality control deficiencies. Procurement and regulatory teams must assess supply chain resilience for Phentolamine Mesylate, as product integrity failures carry significant patient safety and market availability risks.

REGULATORY INTELLIGENCE
2025-12-17

Winder Laboratories Initiates Nationwide Recall of Morphine Sulfate Oral Solution Due to Labeling Error

Winder Laboratories, LLC has initiated a voluntary Class III recall of 3,528 bottles of Morphine Sulfate Oral Solution (ANDA211454) nationwide in the U.S. The recall (D-0223-2026) stems from a critical mispack where carton labels incorrectly stated bottle sizes. This event underscores the persistent need for robust quality control in pharmaceutical packaging operations.

REGULATORY INTELLIGENCE
2025-12-17

Cipla USA, Inc. Initiates Class II Recall of Lanthanum Carbonate Chewable Tablets Due to Hardness Failure

Cipla USA, Inc. has initiated a Class II recall for Lanthanum Carbonate chewable tablets, 1000mg (lot NB240315), due to failed stability specifications, specifically an out-of-specification hardness test. This voluntary, nationwide recall impacts 1180 boxes, necessitating immediate action for procurement and supply chain teams to mitigate disruption and ensure patient safety within the US market.

REGULATORY INTELLIGENCE
2025-12-17

Dr. Reddy's Varenicline Recall: Sub-Potency Issue Disrupts US Supply Chains

Dr. Reddy's Laboratories, Inc. has initiated a nationwide Class III recall for Varenicline Tablets, 1mg, due to sub-potency. This voluntary action, affecting 4800 bottles of Lot F2400244, stems from stability test failures where assay values fell below specifications. Procurement and supply chain leaders must immediately assess inventory and identify alternative Varenicline Tartrate sources to mitigate market disruption.

REGULATORY INTELLIGENCE
2025-12-17

Glenmark Pharmaceuticals Inc. Initiates Class III Nebivolol Recall Amid Cross-Contamination Concerns

Glenmark Pharmaceuticals Inc., USA, has initiated a Class III recall for 672 bottles of Nebivolol Tablets, 20 mg, due to cross-contamination. This event highlights critical manufacturing quality control failures at its Pithampur, India facility, demanding immediate reassessment by procurement and regulatory teams to mitigate supply chain risks and ensure product integrity.

REGULATORY INTELLIGENCE
2025-12-17

Cipla USA Initiates Class II Recall of Cinacalcet Hydrochloride Tablets Over Nitrosamine Impurity Exceeding ADI Limits

Cipla USA, Inc. has initiated a Class II voluntary recall of 12,576 bottles of Cinacalcet Hydrochloride Tablets (90 mg, Lot 5PB0183) due to N-nitroso-cinacalcet impurity levels exceeding acceptable daily intake limits. This nationwide U.S. recall, effective November 14, 2025, underscores critical CGMP deviations impacting product safety and regulatory compliance for Cipla USA, Inc.

REGULATORY INTELLIGENCE
2025-12-17

Lupin Pharmaceuticals Initiates Class II Recall for Ganirelix Acetate Injection Over Impurity Concerns

Lupin Pharmaceuticals, Inc. initiated a Class II recall for 32,736 vials of Ganirelix Acetate Injection (ANDA216075) due to out-of-specification impurities. This voluntary action, impacting distribution in FL, MA, MI, and OH, highlights critical quality control vulnerabilities at the manufacturing site, Lupin Limited in Nagpur, India. Procurement and regulatory teams must assess current inventory, evaluate supply chain resilience for Ganirelix Acetate, and proactively identify alternative qualified suppliers to mitigate potential disruptions and ensure patient access.

REGULATORY INTELLIGENCE
2025-12-17

Fagron Compounding Services Initiates Class II Recall of Ophthalmic Solution Due to Formulation Error, Impacting U.S. Supply

Fagron Compounding Services has initiated a Class II recall for 2,980 syringes of a critical ophthalmic solution due to incorrect formulation. This U.S. nationwide event, impacting the Tropicamide/Cyclopentolate/Phenylephrine/Ketorolac product, underscores significant risks for procurement, regulatory, and supply chain leaders regarding compounded sterile products and the imperative for stringent quality assurance protocols.

REGULATORY INTELLIGENCE
2025-12-10

FDA Class II Recall: Park Avenue Compounding's Phenylephrine HCI Due to CGMP Deviations

Park Avenue Compounding initiated a Class II recall for 858 syringes of Phenylephrine HCI from its Saint Louis, MO facility, citing CGMP deviations. This event underscores critical supply chain vulnerabilities and the imperative for robust quality assurance in pharmaceutical procurement. Decision-makers must reassess supplier qualification and compliance monitoring to mitigate similar regulatory risks.

REGULATORY INTELLIGENCE
2025-12-10

Safecor Health Initiates Class II Recall of Haloperidol Lactate Due to RFID Tag Mislabeling

Safecor Health, LLC has initiated a Class II recall for Haloperidol Lactate Injection due to incorrect RFID tag labels applied by the repackaging firm. This incident, impacting 800 vials distributed in Massachusetts, highlights critical vulnerabilities in third-party labeling processes, demanding immediate review by procurement and regulatory teams to mitigate supply chain risks and ensure patient safety.

REGULATORY INTELLIGENCE
2025-12-10

Cipla USA Inc. Initiates Class II Recall for Phytonadione Injectable Emulsion Due to Stability Failure

Cipla USA Inc. has initiated a Class II recall for 4,438 cartons of Phytonadione Injectable Emulsion, USP 10mg/mL, distributed nationwide. This voluntary action stems from out-of-specification results for color index, indicating a critical stability failure. Procurement and regulatory teams must assess supply chain resilience for this essential Vitamin K product, manufactured by Cipla Ltd. India, to mitigate potential disruption.

REGULATORY INTELLIGENCE
2025-12-10

Blossom Pharmaceuticals Initiates Nationwide Recall of Zinc Oxide Ointment Due to cGMP Deviations

Blossom Pharmaceuticals has initiated a Class II recall of 912 containers of Zinc Oxide Ointment USP, manufactured for Nivagen Pharmaceuticals, Inc., due to cGMP deviations at its Bardej, Goa, India facility. This nationwide USA recall underscores critical quality control lapses, demanding immediate assessment by procurement and regulatory teams. Decision-makers must evaluate supply chain vulnerabilities and enhance due diligence for contract manufacturing partners, particularly those in India.

REGULATORY INTELLIGENCE
2025-12-10

Blossom Pharmaceuticals Initiates Nationwide Recall of Zinc Oxide Ointment Over cGMP Deviations

Blossom Pharmaceuticals has initiated a voluntary Class II recall of 33,000 containers of Globe Zinc Oxide Ointment USP 20% due to cGMP deviations at its Bardej, Goa, India facility. This action, impacting USA nationwide distribution by Trifecta Pharmaceuticals USA, signals critical supply chain vulnerabilities and heightened regulatory scrutiny for procurement and regulatory affairs teams managing topical OTC drug portfolios.

REGULATORY INTELLIGENCE
2025-12-10

Blossom Pharmaceuticals Initiates Class II Recall of Dynashield Skin Protectant Over cGMP Deviations in India

Blossom Pharmaceuticals has initiated a Class II recall of 1,560 units of Dynashield Skin Protectant (Zinc Oxide) due to cGMP deviations at its Bardej, Goa, India facility. This impacts Dynarex Corporation and US nationwide distribution, signaling critical supply chain and regulatory risks for procurement and regulatory affairs teams.

REGULATORY INTELLIGENCE
2025-12-10

Nivagen Zinc Oxide Ointment Recalled Nationwide Over Critical cGMP Deviations from India Facility

Nivagen Pharmaceuticals faces a Class II recall for 7,920 bottles of Zinc Oxide Ointment USP distributed nationwide. Initiated by Blossom Pharmaceuticals due to cGMP deviations at an Indian facility, this event signals critical quality control lapses. Procurement and regulatory teams must reassess supplier qualification and supply chain resilience for topical drug ingredients from the region.

REGULATORY INTELLIGENCE
2025-12-10

FDA Initiates Class II Recall for Trifecta Pharmaceuticals' Clotrimazole Cream Amid cGMP Deviations from Indian Manufacturer Blossom

Trifecta Pharmaceuticals USA LLC faces a Class II recall for 12,150 bottles of Globe Clotrimazole Cream, USP, 1%, distributed nationwide. The recall, initiated by Blossom Pharmaceuticals in India, stems from critical cGMP deviations. This event underscores significant supply chain vulnerabilities and heightens regulatory scrutiny on overseas manufacturing, demanding immediate action from procurement and regulatory teams to mitigate disruption.

REGULATORY INTELLIGENCE
2025-12-10

Actavis Pharma's Testosterone Gel Recalled by FDA Over Container Seal Defects, Impacting U.S. Supply

Actavis Pharma, Inc. faces a Class III recall for 15,944 cartons of Testosterone Gel 1% due to defective container side-seals causing product leakage. This U.S. nationwide recall, initiated by Teva Pharmaceuticals USA, Inc., highlights critical quality control vulnerabilities in packaging integrity. Procurement and regulatory teams must scrutinize supplier quality systems and container closure integrity to mitigate supply chain disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2025-12-10

FDA Initiates Class II Recall for Breckenridge Pharmaceutical's Duloxetine Due to N-Nitroso Impurity and CGMP Deviations

Breckenridge Pharmaceutical, Inc. has initiated a Class II recall for 7,389 bottles of Duloxetine Delayed-Release Capsules, USP, 60 mg, distributed nationwide in the U.S. This action, stemming from CGMP deviations and N-nitroso-duloxetine impurity exceeding FDA limits, necessitates immediate review of supply chain resilience and quality assurance protocols for all stakeholders sourcing or distributing generic antidepressant medications.

REGULATORY INTELLIGENCE
2025-12-03

FDA Class II Recall: CA BOTANA International's Elixir Sunscreen Pulled Over CGMP Deviations

CA BOTANA International, Inc. has initiated a voluntary Class II recall for its Elixir by Coco March Tinted Mineral Sunscreen SPF 50 due to CGMP deviations. This action impacts distribution across CA, CO, FL, PR, and WA, demanding immediate attention from procurement and regulatory teams to assess supply chain integrity and compliance risks.

REGULATORY INTELLIGENCE
2025-12-03

CA BOTANA International Initiates Class II Recall for Benzoyl Peroxide Cream Due to CGMP Deviations

CA BOTANA International initiated a voluntary Class II recall for 470 tubes of Doctor D. Schwab Controlling Cream (Benzoyl Peroxide 2.7%) due to CGMP deviations. This event, impacting distribution across five U.S. states and Puerto Rico, signals critical quality control vulnerabilities for procurement and regulatory teams, necessitating immediate supply chain and compliance review.

REGULATORY INTELLIGENCE
2025-11-26

FDA Initiates Class II Recall for DermaRite's KleenFoam Antimicrobial Foam Soap Over CGMP Deviation

DermaRite Industries, LLC faces an FDA Class II recall for 15,267 cartridges of KleenFoam Antimicrobial Foam Soap (Chloroxylenol 0.5%). This action stems from a CGMP deviation at its North Bergen, NJ facility, where other products were found contaminated. Procurement and regulatory teams must assess supply chain continuity and quality assurance protocols for similar products.

REGULATORY INTELLIGENCE
2025-11-26

FDA Class II Recall: Golden State Medical Supply's Niacin Extended-Release Tablets Fail Dissolution

Golden State Medical Supply Inc. has initiated a Class II recall for 24,869 bottles of NIACIN Extended-Release Tablets, 1,000 mg, due to failed dissolution specifications. This nationwide recall impacts patient treatment for dyslipidemia, necessitating immediate supply chain review and alternative sourcing strategies for procurement directors and regulatory affairs heads to mitigate disruption.

REGULATORY INTELLIGENCE
2025-11-26

Alembic Pharmaceuticals' Fesoterodine Fumarate Recall: Impurity Breach Impacts US Supply

Alembic Pharmaceuticals Limited has initiated a Class III recall for Fesoterodine Fumarate Extended-release Tablets due to 'Diester Impurity' exceeding limits. This voluntary action, impacting 4,884 bottles distributed nationwide in the USA, signals a critical quality control lapse at their Panelav, India facility. Procurement and regulatory teams must assess supply chain exposure and evaluate alternative sourcing strategies immediately.

REGULATORY INTELLIGENCE
2025-11-26

ICU Medical Inc. Faces Class I Recall for Potassium Chloride Injection Due to Critical Labeling Error

ICU Medical Inc. has initiated a Class I recall for its Potassium Chloride Injection (NDA020161) due to a critical labeling error, misidentifying 10 mEq as 20 mEq. This poses a severe, potentially fatal, patient safety risk. Procurement directors and supply chain VPs must immediately audit existing inventory and supplier quality controls for all critical injectable products. Regulatory affairs must prepare for heightened FDA scrutiny following this nationwide distribution event.

REGULATORY INTELLIGENCE
2025-11-26

Park Avenue Compounding Recalls Fentanyl Citrate/Ropivacaine Due to CGMP Deviations

Park Avenue Compounding has initiated a Class II recall (D-0178-2026) for 189 bags of Fentanyl citrate / Ropivacaine combination, a Schedule II controlled substance, distributed in Missouri. The recall stems from Current Good Manufacturing Practice (CGMP) deviations, specifically a revised interpretation of Acceptable Quality Level (AQL) results. This event highlights critical compliance risks in sterile compounding, necessitating immediate review of quality control protocols for pharmaceutical procurement and regulatory compliance teams.

REGULATORY INTELLIGENCE
2025-11-26

DermaRite Industries Recalls DermaFungal Cream Over CGMP Deviation and Contamination Risk

DermaRite Industries, LLC has initiated a nationwide Class II recall (D-0162-2026) for its DermaFungal Antifungal Cream containing 2% Miconazole Nitrate. The recall, impacting 1,480 packets, stems from a Current Good Manufacturing Practice (CGMP) deviation at its North Bergen, NJ facility, where other products were found contaminated. This event underscores critical supply chain vulnerabilities for procurement and regulatory teams sourcing topical antifungal agents, necessitating immediate risk assessment and potential diversification strategies to mitigate disruption.

REGULATORY INTELLIGENCE
2025-11-26

Zydus Pharmaceuticals Initiates Class II Recall of Bromocriptine Mesylate Capsules Due to Impurity Failure

Zydus Pharmaceuticals (USA) Inc. has initiated a Class II recall of 36,624 bottles of Bromocriptine Mesylate Capsules, USP, 5 mg, distributed nationwide. This voluntary action, stemming from an out-of-specification result for 2-Bromoergine impurity, highlights critical quality control vulnerabilities. Procurement and regulatory teams must assess supply chain stability and supplier qualification processes for this essential molecule.

REGULATORY INTELLIGENCE
2025-11-26

DermaRite Industries Initiates Class II Recall of McKesson Skin Protectant Due to CGMP Deviations and Contamination

DermaRite Industries, LLC has initiated a Class II recall for McKesson Skin Protectant, Lanolin USP, citing Current Good Manufacturing Practice (CGMP) deviations. Products manufactured at its North Bergen, NJ facility were found to be contaminated, posing a significant risk to supply chains. Procurement and regulatory teams must assess immediate inventory impacts and re-evaluate supplier quality oversight.

REGULATORY INTELLIGENCE
2025-11-12

Teva Pharmaceuticals USA Faces Class II Recall for Subpotent Amoxicillin and Clavulanate Potassium Suspension

Teva Pharmaceuticals USA, Inc. has initiated a Class II recall for 4,680 cartons of Amoxicillin and Clavulanate Potassium for Oral Suspension due to subpotent Clavulanate Potassium. This voluntary, firm-initiated action, impacting Mississippi, Ohio, and California, necessitates immediate review by procurement and regulatory teams to assess supply chain integrity and potential product shortages for this critical antibiotic.

REGULATORY INTELLIGENCE
2025-11-12

Aero Healthcare Initiates Class II Recall for AEROTAB PAIN RELIEVER Due to Critical Labeling Error

Aero Healthcare has issued a Class II recall for AEROTAB PAIN RELIEVER (NDC 55305-135) nationwide, initiated October 17, 2025. This stems from a critical labeling mix-up where outer packaging incorrectly lists Acetaminophen 500mg and Caffeine 65mg, while inner pouches correctly state Aspirin 500mg and Caffeine 32.5mg. This poses significant patient safety risks, demanding immediate attention from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-11-05

QuVa Pharma Initiates Class II Recall for 75,885 R.E.C.K. Syringes Due to Particulate Matter

QuVa Pharma, Inc. has initiated a U.S. nationwide Class II recall for 75,885 syringes of its compounded R.E.C.K. solution from its Sugar Land, TX facility. This voluntary action, prompted by particulate matter, impacts periarticular pain management. Procurement and regulatory teams must assess supply chain vulnerabilities and reinforce quality assurance protocols for compounded injectables, given the critical nature of such products.

REGULATORY INTELLIGENCE
2025-11-05

ProRx LLC Initiates Class II Recall of Semaglutide Injection Due to Sterility Concerns, Marking Second Such Event

ProRx LLC has initiated a Class II recall of 2,649 vials of Semaglutide Injection (2.5mg/1mL) due to a lack of sterility assurance. This marks the second sterility-related recall for ProRx LLC in just over a year, raising significant concerns for procurement and regulatory teams regarding supply chain reliability and patient safety from compounded products.

REGULATORY INTELLIGENCE
2025-11-05

Endo USA Initiates Nationwide Recall of Everolimus Tablets Due to Impurity IP-C Out-of-Specification

Endo USA, Inc. has initiated a Class III recall for 1,866 cartons of Everolimus tablets 7.5mg across the U.S. due to out-of-specification impurity IP-C. This voluntary action, stemming from manufacturing by Par Pharmaceutical, highlights critical quality control lapses. Procurement and regulatory teams must assess supply chain vulnerabilities and ensure robust quality assurance for this vital immunosuppressant.

REGULATORY INTELLIGENCE
2025-11-05

FDA Class II Recall: Heritage Pharmaceuticals' Desipramine Hydrochloride Tablets Hit by N-Nitroso Impurity

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. initiated a Class II recall for Desipramine Hydrochloride Tablets due to N-Nitroso Desipramine impurity exceeding acceptable limits. This event, linked to manufacturing by USV Private Limited in India, signals critical CGMP deviations. Procurement and regulatory teams must assess supply chain vulnerabilities for Desipramine Hydrochloride and enhance impurity testing protocols to mitigate commercial and patient safety risks.

REGULATORY INTELLIGENCE
2025-11-05

Kenvue Brands LLC Initiates Class II Recall for TYLENOL Extra Strength Due to Defective Container

Kenvue Brands LLC has initiated a voluntary Class II recall for a specific lot of TYLENOL Extra Strength (Acetaminophen 500mg) due to a defective container. This action, affecting 3,816 bottles distributed nationwide, underscores critical packaging quality control for OTC drugs. Procurement and regulatory teams must assess supply chain vulnerabilities and ensure compliance with FDA standards.

REGULATORY INTELLIGENCE
2025-11-05

FDA Class II Recall: Otsuka ICU Medical LLC Withdraws 509,360 Units of Sodium Chloride Injection Over Sterility Concerns

Otsuka ICU Medical LLC has initiated a Class II recall of 509,360 units of 0.9% Sodium Chloride Injection, USP, 100 mL, distributed nationwide in the USA. The recall, impacting Lot # 1029921, stems from a lack of sterility assurance due to potential flexible container leaks. Procurement and supply chain teams must immediately assess inventory and secure alternative sources for this critical intravenous solution.

REGULATORY INTELLIGENCE
2025-11-05

FDA Class II Recall for ACME UNITED CORPORATION's Sting Relief Swabs Signals Critical Product Mix-up and Supply Chain Risk

ACME UNITED CORPORATION faces an FDA Class II recall for 2,338 boxes of Sting Relief Swabs (Lot #: 2251994) due to a critical product mix-up. This nationwide recall, initiated September 23, 2025, signals significant quality control failures impacting supply chain integrity and brand reputation. Procurement and regulatory teams must assess ACME UNITED's remediation plans to mitigate future supply disruptions and ensure product safety.

REGULATORY INTELLIGENCE
2025-11-05

FDA Class II Recall: Amerisource Health Services Withdraws Prazosin Hydrochloride Due to Carcinogenic Nitrosamine Impurity

Amerisource Health Services LLC has initiated a Class II recall (D-0103-2026) of Prazosin Hydrochloride capsules due to N-nitroso Prazosin impurity C exceeding acceptable limits. This event, impacting 3,410 cartons distributed nationwide, signals heightened FDA scrutiny on nitrosamine contamination. Procurement directors and regulatory affairs heads must reassess supply chain integrity and quality control protocols to mitigate significant commercial and compliance risks.

REGULATORY INTELLIGENCE
2025-11-05

ProRx LLC Faces Second Sterility Recall for Compounded Semaglutide Injection, Raising Supply Chain Risks

ProRx LLC has initiated a Class II recall of 8,310 vials of Semaglutide Injection due to a lack of sterility assurance, impacting distribution in Texas and Utah. This marks the second sterility-related recall for ProRx LLC's compounded injectables within a year, following a Tirzepatide recall in 2024. Procurement and regulatory teams must immediately assess supply chain exposure and re-evaluate ProRx LLC's reliability as a sterile drug manufacturer.

REGULATORY INTELLIGENCE
2025-11-05

FDA Initiates Class II Recall for Breckenridge Pharmaceutical's Duloxetine Due to N-nitroso-duloxetine Impurity

Breckenridge Pharmaceutical, Inc. has initiated a Class II recall for 172,263 bottles of Duloxetine Delayed-Release Capsules, USP, 60 mg, distributed nationwide in the U.S. This action stems from Current Good Manufacturing Practice (CGMP) deviations, specifically the presence of N-nitroso-duloxetine impurity exceeding the 12.5ppm safety assessment limit. This event necessitates immediate attention from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-11-05

Sun Pharma Initiates Class II Recall of Lisdexamfetamine Dimesylate Capsules Due to Failed Dissolution Specifications

Sun Pharmaceutical Industries, Inc. has initiated a U.S. Nationwide Class II recall for specific lots of Lisdexamfetamine Dimesylate Capsules, 20 mg, manufactured by OHM Laboratories. This action stems from failed dissolution specifications observed during stability testing, posing significant compliance and supply chain risks for procurement and regulatory teams managing Lisdexamfetamine Dimesylate sourcing.

REGULATORY INTELLIGENCE
2025-11-05

FARMAKEIO OUTSOURCING LLC Initiates Class II Recall for Testosterone/Triamcinolone Pellets Amid Metal Particulate Risk

FARMAKEIO OUTSOURCING LLC initiated a Class II recall (D-0130-2026) for 18,124 Testosterone / Triamcinolone Acetonide sterile pellets due to CGMP deviations and potential metal particulate matter. This nationwide U.S. and Antigua distribution event highlights critical risks in sterile compounding. Procurement and regulatory teams must assess supply chain integrity and reinforce quality assurance protocols to mitigate similar compliance exposures.

REGULATORY INTELLIGENCE
2025-11-05

Teva Pharmaceuticals Recalls Prazosin Hydrochloride Nationwide Over Carcinogenic Nitrosamine Impurity

Teva Pharmaceuticals USA, Inc. has initiated a U.S. nationwide Class II recall for 291,512 bottles of Prazosin Hydrochloride Capsules. The action stems from Current Good Manufacturing Practices (CGMP) deviations, specifically N-nitroso Prazosin impurity C exceeding acceptable carcinogenic intake limits. This event underscores critical supply chain vulnerabilities and heightened regulatory scrutiny on nitrosamine contamination in generic pharmaceuticals.

REGULATORY INTELLIGENCE
2025-10-29

ibspot Initiates Class II Recall for Unapproved Taoscare Motion Sickness Patches: Critical Regulatory Compliance Failure

ibspot has initiated a Class II recall for Taoscare Motion Sickness Patches due to marketing without an approved NDA/ANDA. This regulatory non-compliance, involving products manufactured by Henan Xinyongtal Medical Technology, highlights critical risks for distributors and procurement. Businesses must verify supplier regulatory approvals to avoid supply chain disruptions and legal liabilities associated with unapproved drug products.

REGULATORY INTELLIGENCE
2025-10-29

The Harvard Drug Group LLC Initiates Nationwide Recall of Gabapentin Capsules Due to Impurity Concerns

The Harvard Drug Group LLC has initiated a Class II nationwide recall of Gabapentin Capsules, USP, 100 mg, due to out-of-specification impurity levels identified during stability testing. This voluntary action impacts multiple lots, necessitating immediate review by procurement and regulatory teams to assess supply chain stability and ensure patient safety. The event underscores the critical need for robust quality control in pharmaceutical distribution.

REGULATORY INTELLIGENCE
2025-10-29

FDA Class III Recall: JB Chemicals' Cetirizine Hydrochloride Tablets Affected by Imprinting Error

JB Chemicals and Pharmaceuticals Ltd has initiated a Class III recall of 13,440 bottles of Cetirizine Hydrochloride Tablets USP 10 mg due to incorrect tablet imprinting. Distributed U.S. nationwide by Rising Pharma Holdings, Inc., this event highlights critical quality control gaps at the Mumbai, India manufacturing facility, impacting supply chain integrity and demanding immediate action from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-10-29

FDA Regulatory Action: Church & Dwight's Zicam Elderberry Drops Recalled Over Labeling Non-Compliance

Church & Dwight Co., Inc. faces FDA regulatory action, initiating a Class II recall for 21,912 bottles of Zicam Cold Remedy Medicated Fruit Drops - Elderberry due to undeclared elderberry. This significant enforcement highlights critical compliance gaps in OTC drug labeling, posing substantial supply chain and regulatory risks for global chemical and life sciences firms. Procurement and regulatory teams must scrutinize ingredient declarations rigorously.

REGULATORY INTELLIGENCE
2025-10-29

Aspiro Pharma's Ketorolac Tromethamine Injection Recalled Nationwide by FDA Due to Glass Particulates

Aspiro Pharma Limited has initiated a nationwide Class II recall for multiple lots of Ketorolac Tromethamine Injection, USP, due to glass particulate matter. This action, impacting a critical pain management drug, necessitates immediate supply chain review for procurement directors and regulatory heads. The recall highlights persistent quality control challenges in sterile injectables, demanding enhanced supplier qualification and vigilance for business continuity.

REGULATORY INTELLIGENCE
2025-10-29

FDA Class II Recall: Bristol-Myers Squibb's Opdualag Faces Sterility Assurance Issues, Impacting 12,778 Vials

Bristol-Myers Squibb Company has initiated a Class II nationwide recall for 12,778 vials of Opdualag (nivolumab and relatlimab-rmbw) injection due to a lack of sterility assurance. This voluntary recall, impacting lot 033A23B, presents significant supply chain and regulatory risks for procurement and regulatory affairs teams. Decision-makers must assess potential supply disruptions and scrutinize supplier quality systems, particularly for sterile injectable oncology treatments, to mitigate patient safety and market access implications.

REGULATORY INTELLIGENCE
2025-10-29

Graviti Pharmaceuticals Initiates Class II Recall for Bupropion Hydrochloride ER 300mg Due to Failed Specifications

Graviti Pharmaceuticals Private Limited has initiated a Class II recall for 46,512 bottles of Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, due to failed tablet specifications. This impacts supply chains relying on the Hyderabad, India facility and its distributor, Rising Pharma Holdings, Inc. Procurement and regulatory teams must assess immediate supply risks and evaluate alternative generic Bupropion sources to mitigate disruption and ensure patient access.

REGULATORY INTELLIGENCE
2025-10-29

Medline Industries Recalls Subpotent Alcohol Prep Pads: Critical Supply Chain Implications

Medline Industries, LP has initiated a Class II recall (D-0035-2026) for 222,800 units of its 70% Isopropyl Alcohol Prep Pads due to subpotency. This nationwide action, impacting NDC 55329-811-30, demands immediate attention from procurement and supply chain leaders to secure compliant alternatives and mitigate patient safety risks from ineffective disinfection.

REGULATORY INTELLIGENCE
2025-10-22

FDA Class II Recall: Amerisource Health Services' Sucralfate Tablets Adulterated Post-Chapter 11 Filing

Amerisource Health Services LLC initiated a Class II recall of 27,868 blister packs of Sucralfate Tablets, USP 1 gram, distributed nationwide. This action stems from the firm's Chapter 11 bankruptcy filing on September 30, 2024, which compromised its ability to maintain CGMP standards, rendering the product adulterated. Procurement and regulatory teams must act swiftly to mitigate supply chain disruption and ensure compliance.

REGULATORY INTELLIGENCE
2025-10-22

FDA Class II Recall: Ascend Laboratories' Atorvastatin Calcium Fails Dissolution, Disrupting U.S. Generic Statin Supply

Ascend Laboratories, LLC has initiated a Class II recall of 141,984 bottles of Atorvastatin Calcium Tablets USP, 10 mg, across the U.S. due to failed dissolution specifications. This event, linked to manufacturing by Alkem Laboratories, Ltd. India, necessitates immediate supply chain reassessment for generic statins, impacting procurement and regulatory compliance strategies for pharmaceutical stakeholders.

REGULATORY INTELLIGENCE
2025-10-22

FDA Class II Recall: SV Labs Prescott Corporation's Sunscreen Fails Microbial Count, Raising cGMP Compliance Concerns

SV Labs Prescott Corporation initiated a Class II recall of Aloe Up Sport Performance Sunscreen Lotion SPF 30 due to cGMP deviations and failed microbial count testing. This event underscores critical supply chain risks for procurement and regulatory teams, highlighting the imperative for stringent quality oversight in contract manufacturing and robust supplier qualification processes to safeguard brand integrity and consumer safety.

REGULATORY INTELLIGENCE
2025-10-22

Glenmark Pharmaceuticals Initiates US Nationwide Recall of Viorele Due to Impurity Failures

Glenmark Pharmaceuticals Inc., USA has initiated a Class II recall of 26,928 packs of Viorele (Desogestrel and Ethinyl Estradiol) across the US due to failed impurity and degradation specifications. This voluntary action impacts supply stability for a critical oral contraceptive, necessitating immediate review of procurement strategies and alternative sourcing options for affected stakeholders in the pharmaceutical supply chain.

REGULATORY INTELLIGENCE
2025-10-22

FDA Class II Recall: Rising Pharma's Carbidopa, Levodopa, Entacapone Tablets Face Mix-Up

Rising Pharma Holdings, Inc. has initiated a Class II recall for Carbidopa, Levodopa, Entacapone Tablets (25 mg/100 mg/200 mg) due to a product mix-up. Bottles labeled for a lower strength were found to contain a higher strength (37.5 mg/150 mg/200 mg) manufactured by Suven Pharmaceuticals Limited. This event highlights critical supply chain quality control vulnerabilities for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-10-22

FDA Class III Recall: STAQ Pharma's Ketamine Injection Faces Labeling Non-Compliance

STAQ Pharma, Inc. has initiated a nationwide Class III recall of Ketamine Hydrochloride Injection due to critical labeling errors concerning lot and expiration dates. This event signals a lapse in GMP, requiring immediate action from procurement and regulatory teams to assess supply chain integrity and ensure compliance with labeling standards for critical medications like Ketamine.

REGULATORY INTELLIGENCE
2025-10-15

Acella Pharmaceuticals Initiates Class II Recall for Doxycycline Hyclate Tablets Due to Dissolution Failure

Acella Pharmaceuticals, LLC has initiated a nationwide Class II recall for 4,680 bottles of Doxycycline Hyclate Tablets, USP 100 mg (Lot P24ZLK1) due to failed dissolution specifications. This voluntary action, reported on October 15, 2025, highlights critical quality control deficiencies impacting product efficacy. Procurement and regulatory teams must assess supply chain stability and identify alternative Doxycycline Hyclate sources to mitigate disruption and ensure patient access.

REGULATORY INTELLIGENCE
2025-10-15

Accord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Due to Stability Failure

Accord Healthcare Inc. has initiated a Class II recall of 54,432 bottles of Levothyroxine Sodium Tablets, 88 mcg, distributed nationwide in the US. This action stems from subpotency identified during long-term stability testing, with assay content falling below approved specifications. This event highlights critical quality control challenges originating from its manufacturer, Intas Pharmaceuticals Limited in India.

REGULATORY INTELLIGENCE
2025-10-15

FDA Class II Recall: RC Outsourcing's Bevacizumab Syringes Pulled Over Sterility Concerns

RC Outsourcing, LLC initiated a Class II recall for 2,669 Bevacizumab syringes from its Lowellville, OH facility due to sterility assurance concerns. This voluntary action, terminated January 5, 2026, impacts nationwide US distribution. Procurement and regulatory teams must scrutinize compounded sterile product suppliers, reinforcing robust quality oversight to mitigate patient safety risks and supply chain disruptions.

REGULATORY INTELLIGENCE
2025-10-15

Dr. Reddy's Succinylcholine Chloride Recall: Preservative Concentration Failure Prompts US Supply Chain Review

Dr. Reddy's Laboratories, Inc. has initiated a Class II recall of 571 vials of Succinylcholine Chloride Injection, USP, distributed nationwide in the USA. The recall, D-0008-2026, stems from out-of-specification results showing decreased preservative concentration during 6-month stability testing. This event necessitates immediate action for procurement and regulatory teams to ensure patient safety and supply continuity.

REGULATORY INTELLIGENCE
2025-10-15

FDA Class II Recall: GenoGenix's Thymosin Beta-4 Injection Faces Sterility Assurance Issues, Impacting US Supply Chains

GenoGenix LLC has initiated a Class II voluntary recall for its Thymosin Beta-4 (TB4) for Injection, 15mg, due to a lack of sterility assurance. This US nationwide recall, impacting lot GG060525-001, necessitates immediate action from procurement and regulatory teams to mitigate patient safety risks and supply chain disruptions for this critical injectable peptide.

REGULATORY INTELLIGENCE
2025-10-15

GenoGenix LLC Initiates Nationwide Recall of Magnesium Chloride for Injection Due to Sterility Concerns

GenoGenix LLC has initiated a US nationwide Class II recall (D-0062-2026) for all lots of Magnesium Chloride for Injection due to a lack of assurance of sterility. This event, originating from their Boca Raton, FL facility, impacts 430 units, necessitating immediate action from procurement and regulatory teams to assess supply chain exposure and ensure patient safety.

REGULATORY INTELLIGENCE
2025-10-15

Acuity Specialty Products Initiates Nationwide Recall of AFCO Hand Sanitizer Over Methanol Risk

Acuity Specialty Products, Inc. initiated a US nationwide Class II recall for its AFCO Hand Sanitizer (Product 5515) due to critical cGMP deviations. The firm failed to perform required receipt testing on incoming alcohol components, creating an unmitigated risk of methanol contamination. This event underscores the imperative for robust quality control in chemical supply chains, demanding immediate review of sourcing agreements and product specifications by procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-10-15

Major Pharmaceuticals Initiates Class II Recall for Chlorpromazine HCl Due to N-Nitroso Impurity

The Harvard Drug Group LLC dba Major Pharmaceuticals has initiated a Class II nationwide recall (D-0010-2026) for specific lots of Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg. This voluntary action stems from critical CGMP deviations, specifically the detection of N-Nitroso Desmethyl Chlorpromazine exceeding recommended intake limits. This event signals heightened regulatory scrutiny on nitrosamine impurities, demanding immediate supply chain risk assessment and robust quality control from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-10-15

AvKARE Initiates Nationwide Class II Recall of Norgestimate and Ethinyl Estradiol Tablets Over Content Uniformity Failure

AvKARE has initiated a nationwide Class II recall of 2,192 cartons of Norgestimate and Ethinyl Estradiol Tablets due to failed content uniformity specifications. This event, originating from their Pulaski, TN facility, highlights critical quality control vulnerabilities. Procurement and regulatory teams must assess immediate supply chain risks and AvKARE's extensive history of compliance issues.

REGULATORY INTELLIGENCE
2025-10-08

FDA Class II Recall: Zydus Entecavir Tablets Impact U.S. Supply Chain Due to Impurity Failure

Zydus Pharmaceuticals USA Inc. has initiated a Class II recall of Entecavir Tablets, USP, 1 mg, distributed nationwide. This voluntary action, stemming from an out-of-specification organic impurity, directly impacts procurement strategies and patient access. Decision-makers must assess supply chain vulnerabilities and monitor Zydus Lifesciences Ltd.'s remediation efforts to mitigate potential disruptions for this critical antiviral.

REGULATORY INTELLIGENCE
2025-10-08

Apotex Corp. Initiates Nationwide Recall of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution Over Sterility Concerns

Apotex Corp. has initiated a Class II nationwide recall of 151,034 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution due to sterility assurance failures and improper bottle sealing. This event, impacting ANDA091442, signals critical supply chain vulnerabilities for procurement and regulatory teams reliant on Apotex's sterile product manufacturing in Canada, demanding immediate risk assessment and mitigation strategies.

REGULATORY INTELLIGENCE
2025-10-08

FDA Class II Recall: Zydus Pharmaceuticals' Entecavir Tablets Hit by Impurity Failure, Impacting US Supply

Zydus Pharmaceuticals USA Inc. has initiated a Class II recall for 912 bottles of Entecavir Tablets, USP, 0.5 mg, due to out-of-specification organic impurity levels. This voluntary, nationwide recall, stemming from product manufactured by Zydus Lifesciences Ltd. in India, highlights critical quality control challenges. Procurement and regulatory teams must assess immediate supply chain stability for Entecavir and scrutinize supplier quality assurance protocols to mitigate future disruption risks.

REGULATORY INTELLIGENCE
2025-10-01

Medline Industries Recalls Subpotent Povidone-Iodine 10% Solution: Key Regulatory and Supply Chain Implications

Medline Industries, LP has initiated a nationwide Class III recall of 2,680 bottles of subpotent Povidone-Iodine 10% Solution. This event highlights critical quality control vulnerabilities for topical antiseptics, impacting procurement and regulatory affairs teams. Decision-makers must assess supply chain resilience and internal quality assurance protocols to mitigate similar risks and ensure product efficacy.

REGULATORY INTELLIGENCE
2025-10-01

FDA Class II Recall: Private Label Skin Care Inc. Benzoyl Peroxide Cleanser Contaminated with Benzene

Private Label Skin Care Inc. has initiated a Class II recall for its Benzaderm BPO Cleanser 10% due to elevated benzene levels. This event, impacting products distributed in California and Georgia, underscores critical supply chain vulnerabilities in dermatological product manufacturing. Procurement and regulatory teams must immediately reassess quality control for benzoyl peroxide APIs and private label partnerships to mitigate significant health and compliance risks.

REGULATORY INTELLIGENCE
2025-10-01

Granules Pharmaceuticals Initiates Class III Recall for Amphetamine Mixed Salts Due to Impurity Failures

Granules Pharmaceuticals Inc. has initiated a Class III recall (D-0672-2025) for 11,909 bottles of Dextroamphetamine/Amphetamine mixed salts extended-release capsules from its Chantilly, VA facility. This voluntary, firm-initiated recall, distributed nationwide, stems from the product failing impurity and degradation specifications. Procurement and regulatory teams must assess supply chain exposure and monitor Granules' remediation efforts closely.

REGULATORY INTELLIGENCE
2025-10-01

Kroger 70% Isopropyl Alcohol Recalled Nationwide by Consumer Product Partners, LLC Over Cross-Contamination Concerns

Consumer Product Partners, LLC initiated a nationwide Class III recall (D-0660-2025) of Kroger 70% Isopropyl Alcohol due to cross-contamination. This event underscores critical supply chain vulnerabilities and the imperative for robust quality control, impacting procurement strategies and regulatory compliance for firms sourcing over-the-counter pharmaceuticals and chemicals.

REGULATORY INTELLIGENCE
2025-10-01

Granules Pharmaceuticals Initiates Class III Recall for Amphetamine Mixed Salts ER Capsules Over Impurity Failures

Granules Pharmaceuticals Inc. has initiated a Class III recall (D-0669-2025) for 3,384 bottles of its Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules. This voluntary, firm-initiated action stems from the product failing impurity and degradation specifications, impacting nationwide distribution from its Chantilly, VA facility. Procurement and regulatory teams must assess supply continuity and quality assurance protocols.

REGULATORY INTELLIGENCE
2025-10-01

Glenmark Pharmaceuticals Initiates Class II Recall for Azelaic Acid Gel Due to CGMP Deviations and Gritty Texture Complaints

Glenmark Pharmaceuticals Inc., USA has initiated a Class II voluntary recall for 13,824 tubes of Azelaic Acid Gel, 15%, citing CGMP deviations related to a gritty texture. This event, stemming from their Goa, India manufacturing facility, demands immediate attention from procurement and regulatory teams to assess supply chain stability and product quality risks for this topical generic.

REGULATORY INTELLIGENCE
2025-10-01

FDA Initiates Class III Recall for TopCare Health 70% Isopropyl Alcohol Due to Cross-Contamination

Consumer Product Partners, LLC has initiated a Class III recall for 60 bottles of TopCare Health 70% Isopropyl Alcohol due to cross-contamination. This event underscores critical supply chain and quality control vulnerabilities for distributors and retailers of OTC products. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate similar risks and ensure product integrity.

REGULATORY INTELLIGENCE
2025-09-24

Ascend Laboratories Faces FDA Scrutiny Over Superpotent Aripiprazole Recall

Ascend Laboratories, LLC has initiated a Class II recall of 2,256 bottles of Aripiprazole Tablets, USP, 10 mg, due to superpotency. This voluntary, firm-initiated action impacts nationwide distribution in the USA, raising critical questions for procurement and regulatory teams regarding quality control and supplier oversight, particularly with contract manufacturers like Alken Laboratories Ltd. of India.

REGULATORY INTELLIGENCE
2025-09-24

Sandoz Inc. Initiates Class II Recall of Cyclophosphamide Injection Over Temperature Excursion

Sandoz Inc. has initiated a Class II recall (D-0651-2025) for 6 vials of Cyclophosphamide Injection 500 mg/5 mL distributed nationwide, citing a critical cGMP deviation: temperature excursion during transportation. This event underscores significant cold chain vulnerabilities within Sandoz's complex global supply network, demanding immediate attention from procurement and regulatory teams to assess continuity risks for this essential hazardous drug.

REGULATORY INTELLIGENCE
2025-09-24

Fagron Sterile Services Initiates Class II Recall of 109,320 Bevacizumab (Avastin) Syringes Over Sterility Concerns

Fagron Compounding Services has initiated a Class II recall for 109,320 units of bevacizumab (Avastin) injection due to a lack of sterility assurance. This nationwide recall from their Wichita, KS facility poses significant supply chain risks for critical oncology and ophthalmology treatments, demanding immediate action from procurement and regulatory teams to mitigate patient impact and ensure compliance.

REGULATORY INTELLIGENCE
2025-09-24

American Health Packaging Initiates Class II Recall of Chlorpromazine HCl Tablets Over Packaging Contamination

American Health Packaging has initiated a Class II recall for specific lots of Chlorpromazine Hydrochloride Tablets, 200 mg, due to microbial contamination on packaging coil. This voluntary, firm-initiated action impacts nationwide U.S. distribution. Procurement and regulatory teams must assess supply chain stability for this critical antipsychotic, ensuring continuity while monitoring American Health Packaging's remediation efforts for compliance and product availability.

REGULATORY INTELLIGENCE
2025-09-24

FDA Class I Recall: Unichem Pharmaceuticals' Cyclobenzaprine Label Mix-Up Demands Immediate Supply Chain Review

Unichem Pharmaceuticals (USA), Inc. has initiated a Class I recall (D-0655-2025) for Cyclobenzaprine Hydrochloride Tablets due to a critical label mix-up. Bottles were incorrectly filled with Meloxicam USP, 7.5mg tablets, posing significant patient safety risks. This event underscores the imperative for robust quality control in pharmaceutical manufacturing and demands immediate supply chain vigilance from procurement and regulatory teams to mitigate disruption and ensure patient safety.

REGULATORY INTELLIGENCE
2025-09-24

B. Braun Medical Inc. Initiates Class II Recall of Sterile Water for Injection Due to Sterility Concerns

B. Braun Medical Inc. has initiated a Class II recall of 26,316 units of STERILE WATER FOR INJECTION USP (3000mL bags) due to potential port misalignment and sterility compromise. This U.S. nationwide recall (D-0652-2025) impacts critical intravenous supply chains, demanding immediate action from procurement and regulatory teams to ensure patient safety and maintain supply continuity.

REGULATORY INTELLIGENCE
2025-09-24

Sun Pharma Recalls Technetium Tc 99m Mertiatide Kits Over Dissolution Failure, Highlighting Systemic Quality Risks

Sun Pharmaceutical Industries Inc. has initiated a Class II recall of 1,870 kits of Technetium Tc 99m Mertiatide due to failed dissolution specifications, specifically an out-of-specification observation for sulphate in Sodium Tartrate Dihydrate. This event underscores persistent quality control challenges for Sun Pharma, demanding immediate supply chain risk assessment and diversification strategies from procurement directors and regulatory affairs heads.

REGULATORY INTELLIGENCE
2025-09-24

Zydus Pharmaceuticals Recalls Entecavir Tablets Nationwide Due to Impurity Failures: Supply Chain and Regulatory Implications

Zydus Pharmaceuticals (USA) Inc. has initiated a U.S. nationwide Class II recall for 4,344 bottles of Entecavir Tablets, USP, 0.5 mg, due to failed impurity/degradation specifications. This event, originating from Zydus Lifesciences Ltd. in India, signals immediate supply chain disruption and heightened quality control scrutiny. Procurement and regulatory teams must assess current inventory and explore alternative sourcing to mitigate supply risks.

REGULATORY INTELLIGENCE
2025-09-17

Zydus Pharmaceuticals (USA) Inc. Initiates Class II Recall of Chlorpromazine Hydrochloride Tablets Due to Nitrosamine Impurity

Zydus Pharmaceuticals (USA) Inc. has initiated a Class II recall for Chlorpromazine Hydrochloride Tablets, USP, 100 mg, distributed nationwide. The recall, D-0637-2025, stems from CGMP deviations, specifically the presence of N-Nitroso Desmethyl Chlorpromazine exceeding acceptable intake limits. This event underscores persistent nitrosamine impurity challenges and necessitates immediate supply chain and regulatory review by industry stakeholders.

REGULATORY INTELLIGENCE
2025-09-17

Sandoz Inc. Initiates Class II Recall for Ciprofloxacin and Dexamethasone Otic Suspension Due to Temperature Abuse

Sandoz Inc. has initiated a Class II recall (D-0626-2025) for 1,680 bottles of Ciprofloxacin and Dexamethasone Otic Suspension, manufactured by Novartis Manufacturing NV, due to temperature abuse. This event underscores critical vulnerabilities in pharmaceutical cold chain integrity. Procurement and supply chain leaders must reassess their temperature-sensitive product handling protocols to mitigate similar risks and ensure patient safety.

REGULATORY INTELLIGENCE
2025-09-17

FDA Class II Recall: World Perfumes Inc.'s Iodo Blanco Iodides Impacted by Defective Containers

World Perfumes Inc. has initiated a Class II recall for 3,900 bottles of Iodo Blanco Iodides, a First Aid Antiseptic, due to defective containers causing leaks. This voluntary action, impacting Florida distribution, highlights critical packaging integrity challenges for OTC drug manufacturers. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate similar supply chain disruptions and ensure consumer safety.

REGULATORY INTELLIGENCE
2025-09-17

AvKARE Initiates Nationwide Class II Recall of Chlorpromazine Hydrochloride Due to Foreign Substance

AvKARE has initiated a nationwide Class II recall of 1,512 cartons of Chlorpromazine Hydrochloride Tablets, 50 mg, due to foreign substance contamination. This event, impacting a critical CNS medication, necessitates immediate supply chain risk assessment for procurement and regulatory teams, underscoring AvKARE's persistent quality control challenges and the need for diversified sourcing strategies.

REGULATORY INTELLIGENCE
2025-09-17

Exela Pharma Sciences Recalls Sodium Bicarbonate Injection Over Arsenic Impurity Concerns

Exela Pharma Sciences, LLC has initiated a Class II recall for its 4.2% Sodium Bicarbonate Injection due to out-of-specification arsenic impurities. This event, recall D-0620-2025, impacts nationwide distribution, necessitating immediate supply chain review for procurement directors. The Lenoir, NC facility is under scrutiny, demanding robust remediation and alternative sourcing strategies.

REGULATORY INTELLIGENCE
2025-09-17

FDA Recall: Grace & Fire's Ultra Violette SPF 50 Sunscreen Exhibits Critical Efficacy Inconsistency

Grace & Fire PTY LTD has initiated a Class II recall for 44,497 tubes of its Ultra Violette Mini SPF Mates kit, including Velvet Screen SPF 50 and Supreme Sunscreen SPF 50, due to inconsistent SPF results ranging from 4 to 64. This significant quality failure, distributed nationwide in the USA, demands immediate attention from procurement and regulatory teams to reassess supplier quality and mitigate brand risk.

REGULATORY INTELLIGENCE
2025-09-17

Zydus Pharmaceuticals' Chlorpromazine Recall Signals Heightened FDA Scrutiny Over Nitrosamine Impurities and CGMP Deviations

Zydus Pharmaceuticals (USA) Inc. has initiated a Class II recall of Chlorpromazine Hydrochloride due to N-Nitroso Desmethyl Chlorpromazine exceeding acceptable limits, stemming from CGMP deviations. This event underscores critical quality control failures at the manufacturing site in Baddi, India, necessitating immediate action from procurement and regulatory teams to assess supply chain risks and ensure product quality.

REGULATORY INTELLIGENCE
2025-09-17

Breckenridge Pharmaceutical Initiates Class II Recall for Duloxetine 30 mg Due to N-Nitrosamine Impurity

Breckenridge Pharmaceutical, Inc. has initiated a Class II recall for 3,591 bottles of Duloxetine Delayed-Release Capsules, 30 mg, lot 240927C. This action stems from CGMP deviations, specifically N-nitroso-duloxetine impurity exceeding interim limits. Supply chain and regulatory leaders must assess inventory, review supplier qualification for N-nitrosamines, and ensure compliance to mitigate disruption and risk.

REGULATORY INTELLIGENCE
2025-09-17

FDA Class II Recall: Major Pharmaceuticals' Sulfamethoxazole and Trimethoprim Tablets Impacted by Packaging Contamination from Amneal

The Harvard Drug Group LLC dba Major Pharmaceuticals has initiated a Class II recall of Sulfamethoxazole and Trimethoprim tablets due to microorganism contamination on auxiliary polyester coil packaging supplied by Amneal Pharmaceuticals LLC. This nationwide recall, D-0624-2025, highlights critical supply chain vulnerabilities in packaging components, demanding immediate action from procurement and quality assurance teams to mitigate disruption and ensure patient safety.

REGULATORY INTELLIGENCE
2025-09-17

FDA Class II Recall: Lannett's Dextroamphetamine Tablets Impact Supply Chain and Regulatory Compliance

Lannett Company Inc. has initiated a Class II recall for 4,848 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets due to foreign tablet contamination. This voluntary recall, stemming from a 5mg tablet found in 10mg bottles, signals critical quality control deficiencies. Procurement and regulatory teams must assess supply chain resilience and potential market disruptions for this controlled substance.

REGULATORY INTELLIGENCE
2025-09-17

FDA Initiates Class II Recall for Sulfamethoxazole and Trimethoprim Due to Packaging Contamination

Cardinal Health 107, LLC faces a Class II FDA recall for Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg. The recall, initiated by The Harvard Drug Group LLC, stems from microorganism detection on auxiliary polyester coil packaging, not the drug itself. This nationwide U.S. distribution disruption highlights critical packaging supplier oversight and quality control needs, impacting procurement and supply chain continuity for this essential antibiotic.

REGULATORY INTELLIGENCE
2025-09-10

DermaRite Industries Faces Class I Recall for DermaSarra External Analgesic Due to Burkholderia cepacia Contamination

DermaRite Industries, LLC initiated a Class I recall (D-0611-2025) for 249 bottles of DermaSarra External Analgesic (Camphor 0.5%) due to contamination with *Burkholderia cepacia*. This nationwide recall, impacting Lot #: 40187.2, signals critical quality control failures. Procurement and regulatory teams must assess supply chain risks and ensure robust microbial testing protocols for non-sterile drug products to mitigate patient safety threats.

REGULATORY INTELLIGENCE
2025-09-10

B. Braun Medical Inc. Initiates Class I Recall of Sodium Chloride Injection Due to Particulate Matter

B. Braun Medical Inc. has initiated a Class I recall for 47,148 containers of 0.9% Sodium Chloride Injection USP due to particulate matter. This nationwide U.S. recall, D-0628-2025, poses significant patient safety risks and immediate supply chain challenges for procurement directors and healthcare providers relying on this critical intravenous solution.

REGULATORY INTELLIGENCE
2025-09-10

FDA Class II Recall: Amneal Pharmaceuticals' Chlorpromazine Hydrochloride Packaging Contamination Prompts Supply Chain Review

Amneal Pharmaceuticals, LLC has initiated a Class II recall for 3,363 bottles of Chlorpromazine Hydrochloride Tablets, USP, 200 mg, due to microbial contamination in packaging materials. This event, originating from its Ahmedabad, India manufacturing site, necessitates immediate supply chain assessment for procurement and regulatory teams, highlighting critical vulnerabilities in packaging material quality control and global pharmaceutical distribution networks.

REGULATORY INTELLIGENCE
2025-09-10

IMMUNOCORE's KIMMTRAK (Tebentafusp-tebn) Subpotency Triggers Class II US Nationwide Recall

IMMUNOCORE, LLC has initiated a Class II recall for 7,572 vials of KIMMTRAK (tebentafusp-tebn) Injection due to subpotency, impacting US nationwide distribution. This voluntary action, initiated June 10, 2025, highlights critical quality control challenges in a complex global supply chain spanning Denmark, the UK, and the US. Procurement and regulatory teams must assess immediate supply risks and ensure robust quality oversight for specialized oncology therapeutics.

REGULATORY INTELLIGENCE
2025-09-10

FDA Class II Recall: Subpotent Semaglutide Injection from Boothwyn Pharmacy LLC Raises Quality Concerns

Boothwyn Pharmacy LLC has initiated a Class II nationwide recall for 186 vials of subpotent Semaglutide, 2.5 mg/mL injection. This event underscores critical quality control vulnerabilities in pharmaceutical compounding. Procurement and regulatory teams must enhance vigilance over supplier potency testing and manufacturing compliance to mitigate significant supply chain and patient safety risks.

REGULATORY INTELLIGENCE
2025-09-03

Baxter Healthcare Corporation Initiates Class II Recall for Acetaminophen Injection Due to Discoloration

Baxter Healthcare Corporation has initiated a Class II recall for 13,000 containers of Acetaminophen Injection (1000 mg/100 mL) due to discoloration. This voluntary, firm-initiated action impacts U.S. nationwide distribution, posing potential supply chain disruptions for a critical intravenous analgesic. Procurement and regulatory teams must assess immediate inventory and evaluate alternative sourcing strategies.

REGULATORY INTELLIGENCE
2025-09-03

Lannett Company Faces FDA Scrutiny After Class II Lisdexamfetamine Dimesylate Labeling Recall

Lannett Company, Inc. initiated a Class II recall for 8,544 bottles of Lisdexamfetamine Dimesylate Capsules due to a critical 40 mg/30 mg label mix-up. This event underscores the imperative for robust quality controls in pharmaceutical packaging. Procurement and regulatory teams must scrutinize supplier compliance to mitigate patient safety risks, supply chain disruptions, and potential for heightened FDA oversight following such fundamental errors.

REGULATORY INTELLIGENCE
2025-09-03

FDA Class II Recall: Medline Industries' Subpotent CURAD Alcohol Prep Pads Signal Critical Supply Chain Risks

Medline Industries, LP faces a Class II FDA recall for 1.64 million subpotent CURAD Alcohol Prep Pads, impacting nationwide distribution. This event highlights critical supply chain vulnerabilities and quality control deficiencies, particularly for products manufactured in India. Procurement and regulatory teams must reassess supplier qualification and product efficacy risks for Isopropyl Alcohol-based OTC drugs to ensure patient safety and compliance.

REGULATORY INTELLIGENCE
2025-08-27

FDA Class II Recall: Taizhou Kangping's BZK Antiseptic Towelettes Face Sterility Assurance Issues

Taizhou Kangping Medical initiated a Class II recall of 3.85 million cartons of BZK Antiseptic Towelettes due to lack of sterility assurance. This impacts US supply chains, particularly in NY, for benzalkonium chloride 0.13% products. Procurement and regulatory teams must act swiftly to secure alternative sterile supplies and mitigate patient safety risks from the China-based manufacturer.

REGULATORY INTELLIGENCE
2025-08-27

FDA Class III Recall: Haleon US Holdings LLC Navigates Sensodyne PRONAMEL Labeling Discrepancy

Haleon US Holdings LLC has initiated a nationwide Class III recall for 46,692 tubes of Sensodyne PRONAMEL Active SHIELD Toothpaste due to a labeling mix-up. This voluntary action, prompted by an outer carton indicating 'Fresh Mint' while the tube stated 'Cool Mint/Whitening', underscores critical supply chain and regulatory compliance challenges for consumer health product manufacturers.

REGULATORY INTELLIGENCE
2025-08-27

FDA Class II Recall: Viona Pharmaceuticals' Tavaborole Topical Solution Faces Discoloration Issue, Impacting Supply Chain

Viona Pharmaceuticals Inc. has initiated a nationwide Class II recall for 3,960 bottles of Tavaborole Topical Solution 5% due to discoloration. This voluntary action, affecting product manufactured by Zydus Lifesciences Ltd. in India, signals critical quality control and supply chain vigilance requirements for procurement directors and regulatory affairs heads managing distributed pharmaceutical products.

REGULATORY INTELLIGENCE
2025-08-27

Cipla USA Initiates Nationwide Class III Recall of Albuterol Sulfate Inhalation Aerosol Due to Stability Failures

Cipla USA, Inc. has initiated a U.S. nationwide Class III recall for 20352 packs of Albuterol Sulfate Inhalation Aerosol (NDC 69097-142-60). The recall, D-0593-2025, stems from failed stability specifications, specifically out-of-specification particle size distribution at the 12-month time point. This event necessitates immediate supply chain assessment and robust quality oversight for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-08-27

Major Pharmaceuticals Initiates Class II Recall of Carvedilol Tablets Due to N-Nitroso Impurity Exceeding FDA Limits

The Harvard Drug Group LLC dba Major Pharmaceuticals has initiated a Class II recall of Carvedilol Tablets USP, 12.5 mg, due to N-Nitroso Carvedilol Impurity-1 (NNCI) levels exceeding the FDA's 4.0 ppm limit. This voluntary nationwide recall of 26,628 cartons signals critical supply chain and regulatory challenges for procurement and quality assurance teams.

REGULATORY INTELLIGENCE
2025-08-20

FDA Class II Recall: Westminster Pharmaceuticals' Metoprolol Tartrate Contaminated with N-nitroso-metoprolol

Westminster Pharmaceuticals LLC has initiated a Class II recall for Metoprolol Tartrate Tablets due to N-nitroso-metoprolol exceeding the Acceptable Daily Intake. This nationwide recall impacts 4,456 bottles, signaling critical supply chain vulnerabilities and heightened regulatory scrutiny on nitrosamine impurities, requiring immediate action from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-08-20

B. Braun Medical Inc. Initiates Class II Recall of 0.9% Sodium Chloride Injection Over Sterility Concerns

B. Braun Medical Inc. has initiated a voluntary Class II recall of 23,100 containers of 0.9% Sodium Chloride Injection USP due to a lack of sterility assurance stemming from potential fluid leakage at weld sites. This event, originating from their Allentown, PA facility, necessitates immediate action for procurement and supply chain leaders to assess exposure and secure alternative supplies of this critical injectable.

REGULATORY INTELLIGENCE
2025-08-20

Glenmark Pharmaceuticals Initiates Class II Recall for Carvedilol Tablets Over Nitrosamine Impurity

Glenmark Pharmaceuticals Inc., USA, has initiated a Class II recall for Carvedilol Tablets due to N-Nitroso Carvedilol I impurity exceeding acceptable limits. This regulatory action highlights critical CGMP deviations at the manufacturing site in India, impacting supply chain stability for this essential cardiovascular drug and demanding immediate risk assessment from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-08-20

Breckenridge Pharmaceutical Recalls Duloxetine Due to Nitrosamine Impurity, Highlighting CGMP Risks

Breckenridge Pharmaceutical, Inc. initiated a Class II recall (D-0580-2025) of Duloxetine Delayed-Release Capsules, 60 mg, due to N-nitroso-duloxetine impurity exceeding FDA limits. This voluntary recall, impacting 1,856 bottles across NJ, AZ, IN, stems from CGMP deviations at manufacturer Towa Pharmaceutical Europe. Procurement and regulatory teams must assess supply chain vulnerabilities and ensure robust quality oversight to mitigate similar nitrosamine-related risks for generic antidepressant formulations.

REGULATORY INTELLIGENCE
2025-08-20

Ascend Laboratories Initiates Class II Recall for Amlodipine and Olmesartan Medoxomil Due to Dissolution Failure

Ascend Laboratories initiated a Class II recall for 8,568 bottles of Amlodipine and Olmesartan Medoxomil Tablets due to failed dissolution specifications, impacting nationwide supply. Procurement and regulatory teams must assess supply chain stability and quality control for combination antihypertensives. This event underscores the critical need for robust supplier qualification and ongoing monitoring in pharmaceutical distribution.

REGULATORY INTELLIGENCE
2025-08-13

Cardinal Health Inc. Initiates Class II Recall of Genentech's Xolair (Omalizumab) Due to Cold Chain Failure

Cardinal Health Inc. has initiated a Class II recall for four units of Genentech's Xolair (omalizumab) due to temperature excursions, indicating CGMP deviations. This incident highlights persistent cold chain vulnerabilities within Cardinal Health's distribution network, following similar recalls for XIGDUO XR and RECOMBINATE. Procurement and supply chain leaders must reassess third-party logistics risks for temperature-sensitive biologics.

REGULATORY INTELLIGENCE
2025-08-13

Alembic Pharmaceuticals Recalls Doxepin Hydrochloride Over Nitrosamine Impurity and CGMP Deviations

Alembic Pharmaceuticals Limited has initiated a Class II recall of 9,492 bottles of Doxepin Hydrochloride Capsules, USP, 10 mg, distributed nationwide in the USA. This voluntary action, effective July 25, 2025, stems from CGMP deviations involving a Nitrosamine Drug Substance Related Impurity exceeding proposed interim limits. This event underscores critical supply chain and regulatory risks for procurement and regulatory affairs teams managing generic antidepressant portfolios.

REGULATORY INTELLIGENCE
2025-08-13

Breckenridge Pharmaceutical Initiates Class II Recall of Duloxetine Due to Nitrosamine Impurity

Breckenridge Pharmaceutical, Inc. has initiated a U.S. nationwide Class II recall for 1,829 bottles of Duloxetine Delayed-Release Capsules, 60mg. The recall, D-0552-2025, stems from Current Good Manufacturing Practices (CGMP) deviations, specifically the presence of N-nitroso-duloxetine impurity exceeding safety limits. This event mandates immediate action for procurement and regulatory teams managing generic antidepressant supply chains.

REGULATORY INTELLIGENCE
2025-08-13

Cardinal Health Faces FDA Class II Recall for RECOMBINATE Due to Repeated Temperature Excursions

Cardinal Health Inc. has initiated a Class II recall for RECOMBINATE, Antihemophilic Factor (Recombinant), 5 mL vials, impacting three units nationwide. The recall, D-0573-2025, stems from CGMP deviations related to product exposure to temperatures outside labeled storage requirements. This marks a concerning pattern, as Cardinal Health faced a similar temperature excursion recall in 2021, signaling systemic cold chain vulnerabilities for procurement and supply chain leaders.

REGULATORY INTELLIGENCE
2025-08-13

FDA Identifies Critical Processing Control Deficiencies at AEQUITA PHARMACY, Triggering Semaglutide Recall

AEQUITA PHARMACY initiated a Class II recall for 176 vials of Semaglutide + Cyanocobalamin injection solution due to a critical lack of processing controls at its Kirkland, WA facility. This event signals heightened FDA scrutiny on sterile compounding, necessitating immediate review of quality systems by procurement and regulatory teams across the chemical and life sciences industry.

REGULATORY INTELLIGENCE
2025-08-13

Direct Rx Initiates Class II Recall of Duloxetine D/R Over Nitrosamine Impurity and CGMP Deviations

Direct Rx has initiated a Class II recall for 16 bottles of Duloxetine D/R, 20 mg, nationwide, citing CGMP deviations and nitrosamine impurity exceeding proposed interim limits. This event necessitates immediate action from procurement and regulatory teams to assess supply chain integrity and reinforce quality assurance protocols against emerging contaminants, impacting future sourcing decisions and compliance strategies.

REGULATORY INTELLIGENCE
2025-08-13

Cardinal Health Inc. Initiates Class II Recall for Genentech's Xolair (Omalizumab) Due to Cold Chain Failure

Cardinal Health Inc. has initiated a Class II recall for Genentech's Xolair (omalizumab injection) due to critical temperature excursions during storage. This event, involving 6 units, highlights persistent cold chain vulnerabilities within Cardinal Health's distribution network. For procurement and regulatory leaders, this underscores the imperative for stringent cold chain audits and diversified supplier strategies to safeguard sensitive biologic supply and ensure patient safety.

REGULATORY INTELLIGENCE
2025-08-06

FDA Class II Recall: Nostrum Laboratories' Sucralfate Tablets Adulterated Amidst Chapter 11 Bankruptcy

Nostrum Laboratories, Inc. faces a Class II FDA recall (D-0547-2025) for 60,608 bottles of Sucralfate Tablets, USP 1 gram. The recall stems from CGMP deviations directly linked to the firm's September 2024 Chapter 11 bankruptcy filing, which prevents adequate quality program oversight. This event signals critical supply chain risks and necessitates immediate action from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-08-06

Pfizer's Bicillin L-A Class II Recall: CGMP Deviations and Particulates Trigger Nationwide Supply Chain Disruption

Pfizer Laboratories Div Pfizer Inc. has initiated a Class II recall for 50,855 vials of Bicillin L-A (penicillin G benzathine injectable suspension) across the U.S. This voluntary action stems from critical CGMP deviations and the presence of particulate matter identified during visual inspection. This event signals significant supply chain risks and mandates immediate review of quality assurance protocols for sterile injectables.

REGULATORY INTELLIGENCE
2025-08-06

Hikma Pharmaceuticals' Lorazepam Injection Faces Class II FDA Recall Over Purity Failures

Hikma Pharmaceuticals USA Inc. initiated a Class II recall for 382,775 vials of Lorazepam Injection due to out-of-specification impurities. This voluntary, firm-initiated action, impacting nationwide U.S. distribution, signals critical quality control challenges at their Berkeley Heights, NJ facility. Procurement and regulatory teams must assess immediate supply chain risks and re-evaluate supplier qualification for this essential benzodiazepine.

REGULATORY INTELLIGENCE
2025-08-06

Lupin Pharmaceuticals Initiates Class II Recall for Amlodipine/Benazepril Due to Incorrect Expiry Dates

Lupin Pharmaceuticals Inc. has initiated a Class II voluntary recall (D-0542-2025) for 7,668 bottles of Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg distributed nationwide in the US. The recall stems from a critical labeling error: products were released with an incorrect February 2027 expiration date instead of the correct January 2027. This event underscores the imperative for robust quality control in pharmaceutical labeling to mitigate supply chain disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2025-08-06

Strides Pharma's Cinacalcet Tablets Recalled Nationwide Due to Failed Dissolution Specifications

Strides Pharma, Inc. has initiated a nationwide Class II recall of 6,672 bottles of Cinacalcet Tablets 90 mg (Lot #: 7715893A) due to critical failed dissolution specifications. This action, stemming from product manufactured by Strides Pharma Science Ltd. in India, poses immediate supply chain risks for procurement directors and regulatory challenges for quality assurance teams. Businesses must assess their reliance on Strides' Cinacalcet supply and evaluate potential sourcing alternatives to mitigate disruption.

REGULATORY INTELLIGENCE
2025-07-30

FDA Class II Recall: Imprimis NJOF's Epinephrine Lidocaine HCL Found Sub-Potent, Impacting US Supply Chains

Imprimis NJOF, LLC initiated a Class II recall for 6,880 vials of Epinephrine Lidocaine HCL due to sub-potency identified during stability testing. This nationwide US recall (D-0535-2025) highlights critical quality control failures, posing efficacy risks for patients. Procurement and regulatory teams must immediately assess their supply chain exposure and reinforce supplier qualification processes to mitigate similar product quality risks.

REGULATORY INTELLIGENCE
2025-07-30

Lupin Pharmaceuticals Initiates Class II Recall of Clomipramine Hydrochloride Capsules Due to Degradation

Lupin Pharmaceuticals Inc. has voluntarily recalled 2,724 bottles of Clomipramine Hydrochloride Capsules USP 25 mg (Lot # M300464) due to out-of-specification degradation products. This Class II recall, initiated on June 27, 2025, and terminated on January 5, 2026, impacts nationwide distribution. Procurement and regulatory teams must assess immediate supply chain exposure and reinforce quality assurance protocols for generic antidepressants.

REGULATORY INTELLIGENCE
2025-07-30

FDA Class II Recall: GlaxoSmithKline's BENLYSTA Impacted by Cold Chain Deviations

GlaxoSmithKline's BENLYSTA (belimumab) faces a Class II voluntary recall initiated by Mckesson Medical-Surgical Inc. due to CGMP deviations, specifically potential temperature excursions during transit. This event, affecting 3 vials distributed across OH, VA, and FL, underscores critical vulnerabilities in pharmaceutical cold chain logistics, demanding immediate attention from supply chain and regulatory leaders to safeguard product integrity and patient safety.

REGULATORY INTELLIGENCE
2025-07-30

McKesson Recalls Amgen's EVENITY Due to Cold Chain Failures: A Recurring Distribution Risk

McKesson Medical-Surgical Inc. is conducting a voluntary Class II recall of Amgen's EVENITY (romosozumab-aqqg) injection due to CGMP deviations and potential temperature excursions during transit. This event, affecting distribution in OH, VA, FL, signals recurring systemic issues in McKesson's cold chain integrity, following similar recalls in 2024. Procurement and regulatory teams must reassess distribution partner compliance to mitigate supply chain risks for temperature-sensitive biologics.

REGULATORY INTELLIGENCE
2025-07-30

Imprimis NJOF, LLC Initiates Class III Recall for Sub-Potent Ophthalmic Solution

Imprimis NJOF, LLC has initiated a Class III recall for 2,890 vials of its Tropicamide-Proparacaine-Phenylephrine-Ketorolac Sterile Ophthalmic Solution due to sub-potency identified during stability testing. This voluntary, firm-initiated action impacts nationwide distribution in the USA, requiring immediate review of inventory and supply chain implications for affected pharmaceutical procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-07-23

FDA Initiates Class III Recall for Qualgen's Testosterone 200 mg Pellets Over Labeling Errors

Qualgen, LLC initiated a Class III recall (D-0517-2025) for 2,832 vials of Testosterone 200 mg Pellets due to incorrect lot numbers on labels, stemming from a printing error. This nationwide recall, ongoing since June 16, 2025, necessitates immediate action from distributors and healthcare providers to verify product authenticity and ensure patient safety, impacting supply chain integrity for compounded hormone therapies.

REGULATORY INTELLIGENCE
2025-07-23

Dr. Reddy's Laboratories Initiates Class II Recall of Omeprazole Due to Foreign Tablet Contamination

Dr. Reddy's Laboratories, Inc. has initiated a Class II recall of 1,476 bottles of Omeprazole Delayed-release Capsules, USP, 20mg, distributed nationwide in the USA. The recall, D-0525-2025, stems from the critical discovery of foreign Divalproex Sodium Extended-Release 250mg tablets within Omeprazole bottles. This event signals significant quality control vulnerabilities at the manufacturing level, demanding immediate attention from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-07-23

Sun Pharma Recalls Lisdexamfetamine Dimesylate 60mg Capsules Over Dissolution Failure

Sun Pharmaceutical Industries Inc. has initiated a Class II recall (D-0516-2025) for 5,448 bottles of Lisdexamfetamine Dimesylate 60mg capsules due to failed dissolution specifications. This voluntary, firm-initiated action, stemming from 9-month stability testing, impacts nationwide distribution. Procurement and supply chain leaders must assess immediate inventory risks and re-evaluate Sun Pharma's recurring quality control challenges, demanding robust corrective actions to mitigate future supply disruptions and regulatory exposure.

REGULATORY INTELLIGENCE
2025-07-23

FDA Class II Recall: Accord Healthcare's Subpotent Levothyroxine Sodium Tablets Impact Supply Chain

Accord Healthcare Inc. has initiated a Class II recall for 82,159 bottles of subpotent Levothyroxine Sodium Tablets, USP, 25 mcg, manufactured by Intas Pharmaceuticals Limited in India. This nationwide recall, due to assay levels below approved specifications, poses significant supply chain risks and necessitates immediate action from procurement and regulatory teams to ensure patient safety and continuity of essential thyroid medication supply.

REGULATORY INTELLIGENCE
2025-07-23

FDA Class II Recall: A.P. Deauville's Antiperspirant Pulled Over CGMP Deviations

A.P. Deauville, LLC has initiated a U.S. nationwide Class II recall for 21,265 cases of its Power Stick for her Roll-On Antiperspirant Deodorant due to Current Good Manufacturing Practice (CGMP) deviations. This action, impacting a key over-the-counter product containing Aluminum Sesquichlorohydrate, signals significant regulatory compliance risks for procurement and regulatory affairs teams. The ongoing recall underscores the critical need for robust quality assurance.

REGULATORY INTELLIGENCE
2025-07-23

Accord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets: US Supply Chain Impact

Accord Healthcare Inc. has initiated a Class II nationwide recall for 9,739 bottles of subpotent Levothyroxine Sodium Tablets, USP, 100 mcg, manufactured by Intas Pharmaceuticals Limited in India. This recall, due to assay levels below approved specifications, impacts US supply chains. Procurement and regulatory teams must assess current inventory, identify alternative sources for this critical thyroid medication, and monitor Accord Healthcare's remediation efforts to mitigate supply disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2025-07-23

FDA Recall Highlights Critical Documentation Lapses in Sterile Compounding at Central Admixture Pharmacy Services, Inc. Los Angeles

Central Admixture Pharmacy Services, Inc. (CAPS) Los Angeles initiated a Class II recall for Peripheral Parenteral Nutrition due to insufficient documentation of daily cleaning in an ISO-5 sterile compounding area. This event underscores the critical need for robust processing controls and meticulous record-keeping in sterile drug manufacturing, impacting procurement and regulatory strategies for compounded preparations. Healthcare providers must verify supplier compliance to mitigate patient risk.

REGULATORY INTELLIGENCE
2025-07-23

FDA Class II Recall: Ascend Laboratories' Rizatriptan Benzoate Tablets Impacted by N-Nitroso Impurity

Ascend Laboratories, LLC has initiated a Class II recall for multiple lots of Rizatriptan Benzoate Tablets due to N-nitroso-dimethyl-rizatriptan impurity exceeding FDA limits. This event signals critical CGMP deviations at the manufacturing site, Alkem Laboratories Ltd. in India, necessitating immediate supply chain review for procurement and regulatory teams focused on migraine treatments.

REGULATORY INTELLIGENCE
2025-07-16

Breckenridge Pharmaceutical Initiates Nationwide Recall of Duloxetine Due to Nitrosamine Impurity and CGMP Deviations

Breckenridge Pharmaceutical, Inc. has initiated a U.S. nationwide Class II recall of Duloxetine Delayed-Release Capsules, 40mg, due to N-nitroso-duloxetine impurity exceeding FDA interim limits and associated CGMP deviations. This event, impacting 12,242 bottles, underscores critical quality control failures at the manufacturing site, Towa Pharmaceutical Europe, S.L., necessitating immediate action for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-07-16

FDA Initiates Class II Recall of KABANA SKIN CARE's GreenScreen Zinc Oxide Sunscreen Over cGMP Violations

KABANA SKIN CARE has initiated a Class II recall for 174 tubes of its GreenScreen Zinc Oxide Sunscreen (NDC: 73369-0001-1) from its Louisville, CO facility, citing cGMP deviations. This voluntary action, affecting lots 405-002 and 405-003 distributed across NJ, FL, and MI, underscores critical quality control lapses. Procurement and regulatory teams must scrutinize supplier cGMP compliance to mitigate supply chain risks and ensure product integrity for consumer safety.

REGULATORY INTELLIGENCE
2025-07-09

FDA Issues Class III Recall for Orient Pharma's Pitavastatin Tablets Over Degradation Issues

Orient Pharma Co., Ltd. Yunlin Plant faces a Class III FDA recall for 20,618 bottles of Pitavastatin Tablets, 1 mg, due to failed impurities/degradation specifications. This voluntary, firm-initiated action impacts Teva Pharmaceuticals' supply, highlighting critical quality control vulnerabilities in contract manufacturing. Procurement and regulatory teams must scrutinize existing supplier qualifications and enhance stability monitoring for Pitavastatin Calcium, assessing immediate supply chain risks and long-term compliance strategies.

REGULATORY INTELLIGENCE
2025-07-09

FDA Inspection Triggers Nationwide Recall of Tailstorm Health's KETAmine Hydrochloride Injection Over Sterility Concerns

Tailstorm Health INC has initiated a Class II nationwide recall of 23,200 vials of KETAmine Hydrochloride Injection due to a lack of sterility assurance identified during an FDA inspection. This event, involving a critical compounded drug, signals heightened regulatory scrutiny on sterile manufacturing. Procurement and regulatory teams must immediately assess supply chain exposure, secure alternative sources, and reinforce robust quality oversight to mitigate patient safety risks and ensure continuity of care.

REGULATORY INTELLIGENCE
2025-07-09

FDA Class III Recall: Orient Pharma's Pitavastatin Tablets Fail Impurity Specifications, Impacting Teva Supply

Orient Pharma Co., Ltd. faces an FDA Class III recall for Pitavastatin Tablets due to failed impurity/degradation specifications. This voluntary, firm-initiated action impacts 57,504 bottles manufactured for Teva Pharmaceuticals, distributed in New Jersey. Procurement and regulatory teams must assess immediate supply chain disruptions and re-evaluate supplier quality oversight for Pitavastatin Calcium.

REGULATORY INTELLIGENCE
2025-07-09

FDA Initiates Class II Recall for Major Pharmaceuticals' Gabapentin Due to Defective Blister Packaging

The FDA has classified a voluntary recall of Major Pharmaceuticals' Gabapentin Capsules, 100 mg, as Class II due to inadequately sealed blister packaging. This affects 23,232 cartons distributed nationwide, posing supply chain risks and necessitating immediate action from procurement and regulatory teams to ensure product integrity and patient safety.

REGULATORY INTELLIGENCE
2025-07-09

Sandoz Inc. Initiates Class I Recall for 208,300 Cefazolin Vials Due to Critical Label Mix-Up

Sandoz Inc. has initiated a Class I recall for 208,300 vials of Cefazolin for Injection, USP, due to a critical label mix-up. Cartons correctly labeled for Cefazolin contained vials mislabeled as penicillin G potassium, though the vials contained Cefazolin. This event, impacting nationwide U.S. distribution, necessitates immediate action for procurement and regulatory teams to assess supply chain integrity and patient safety risks.

REGULATORY INTELLIGENCE
2025-07-09

Church & Dwight's Orajel Baby Teething Swabs Face Class I Recall Over Fungal Contamination

Church & Dwight Inc. has initiated a Class I recall for all lots of Orajel Baby, Cooling Swabs for Teething, distributed nationwide due to fungal contamination. This poses significant health risks for infants and demands immediate attention from procurement, supply chain, and regulatory teams to assess product safety and ensure robust quality assurance protocols for pediatric consumer health products.

REGULATORY INTELLIGENCE
2025-07-02

FDA Class II Recall: Thrive Health Solutions' Tirzepatide Injections Face Sterility Assurance Issues

Thrive Health and Wellness, LLC, dba Thrive Health Solutions, initiated a Class II recall for Tirzepatide Injections (30mg/mL, Lot: H388348) due to a lack of sterility assurance. This nationwide recall, impacting 4 pre-filled syringes, highlights critical quality control vulnerabilities for injectable pharmaceuticals. Procurement and regulatory teams must scrutinize supplier sterility protocols to mitigate supply chain risks.

REGULATORY INTELLIGENCE
2025-07-02

Fresenius Medical Care Recalls 3.6 Million Sodium Chloride Injections Over Sterility Concerns

Fresenius Medical Care Holdings, Inc. has initiated a nationwide Class II recall (D-0490-2025) for 3,651,468 containers of 0.9% Sodium Chloride Injection, USP, due to a lack of sterility assurance. This event, originating from their Waltham, MA operations, necessitates immediate review of supply chain resilience for critical intravenous solutions. Procurement and regulatory teams must assess exposure and contingency plans to mitigate potential disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2025-07-02

FDA Initiates Class II Recall of Advanced Pharmaceutical Technology's Unapproved Testosterone Cypionate Injection

Advanced Pharmaceutical Technology, Inc. faces an FDA Class II recall for its TESTO-200 Testosterone Cypionate Injection, marketed without an approved NDA/ANDA. This event underscores critical regulatory compliance failures, demanding immediate attention from procurement, regulatory affairs, and supply chain leaders to mitigate risks associated with unapproved pharmaceutical products and ensure robust supplier qualification.

REGULATORY INTELLIGENCE
2025-07-02

Pfizer Initiates Class II Recall for DOBUTAMINE Injection Due to Vial Defects

Pfizer Inc. has initiated a Class II voluntary recall for 98,410 vials of DOBUTAMINE Injection, USP, Lot KA5023, due to discoloration and cracked vials. This event underscores critical supply chain vulnerabilities for essential cardiovascular therapeutics, demanding immediate action from procurement and regulatory teams to ensure patient safety and continuity of care for this vital medication.

REGULATORY INTELLIGENCE
2025-07-02

Teva Pharmaceuticals Metoclopramide Recall: Foreign Tablets Prompt FDA Class II Action, Supply Chain Impact Looms

Teva Pharmaceuticals USA, Inc. has initiated a Class II nationwide recall for 36,612 cartons of Metoclopramide Tablets, USP 10 mg, due to the presence of foreign tablets/capsules. This event, stemming from manufacturing in Croatia, necessitates immediate review of procurement strategies and supply chain resilience for this critical generic medication across the United States.

REGULATORY INTELLIGENCE
2025-07-02

Apotex Corp. Initiates Nationwide Class II Recall of Ketorolac Tromethamine Ophthalmic Solution Over Sterility Concerns

Apotex Corp. has launched a nationwide Class II recall for 87,840 bottles of Ketorolac Tromethamine Ophthalmic Solution due to a lack of sterility assurance. This event signals heightened FDA scrutiny on sterile manufacturing, demanding immediate attention from procurement, supply chain, and regulatory affairs executives to mitigate commercial and patient safety risks.

REGULATORY INTELLIGENCE
2025-06-25

Aurobindo Pharma USA Initiates Class II Recall of Amazon Basic Care Acetaminophen Due to cGMP Deviations

Aurobindo Pharma USA Inc. has initiated a voluntary Class II recall of 4,608 bottles of Amazon Basic Care Acetaminophen Tablets, 325 mg, due to confirmed consumer complaints of tablet discoloration, indicating cGMP deviations. This nationwide recall highlights critical quality control vulnerabilities for both manufacturers and private label distributors, necessitating immediate supply chain risk assessment and robust quality assurance protocols for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-06-25

Umary-USA.com Initiates Class I Recall of UNAVY ACIDO HIALURONICO Over Undeclared Potent Drugs

Umary-USA.com initiated a Class I recall of 1,342 bottles of UNAVY ACIDO HIALURONICO due to undeclared Dexamethasone, Diclofenac, and Omeprazole, marketed without FDA approval. This event underscores critical supply chain and regulatory risks for firms distributing dietary supplements or unapproved drugs in the U.S. Businesses must enhance due diligence to avoid severe compliance penalties and reputational damage from tainted products.

REGULATORY INTELLIGENCE
2025-06-18

FDA Class II Recall: Ascend Laboratories' Cephalexin Oral Suspension Fails Impurity Specifications

Ascend Laboratories, LLC has initiated a Class II recall of Cephalexin for Oral Suspension due to out-of-specification impurity levels, specifically Cephalexin Glucose Adduct. This voluntary, firm-initiated action impacts 10,620 bottles distributed nationwide in the USA. Procurement and regulatory teams must assess supply chain vulnerabilities and ensure robust quality oversight for generic antibiotics manufactured by third parties.

REGULATORY INTELLIGENCE
2025-06-18

Zydus Pharmaceuticals Recalls Icosapent Ethyl Capsules Due to Oxidation and Leakage, Raising Supply Chain Quality Concerns

Zydus Pharmaceuticals (USA) Inc. has initiated a Class II recall of 11,616 bottles of Icosapent Ethyl Capsules 1 gram due to oxidation and leakage, resulting in burnt or melted capsules. This event, linked to manufacturer Doppel Farmaceutici s.r.l., highlights critical vulnerabilities in pharmaceutical quality control and supply chain integrity, demanding immediate attention from procurement and regulatory leaders.

REGULATORY INTELLIGENCE
2025-06-18

FDA Class III Recall: Glenmark's Ezetimibe and Simvastatin Tablets Fail Impurity Specifications

Glenmark Pharmaceuticals Inc., USA has initiated a Class III recall for Ezetimibe and Simvastatin Tablets (10mg/40mg) due to out-of-specification (OOS) levels of Anhydro Simvastatin. This nationwide recall impacts 6,759 bottles, highlighting critical quality control failures at the manufacturing level and demanding immediate action from procurement and regulatory teams to ensure patient safety and supply chain integrity.

REGULATORY INTELLIGENCE
2025-06-18

FDA Class I Recall: SAINI TRADE INC's ELECTRO BUZZ Tainted with Undeclared APIs, Posing Severe Risk

SAINI TRADE INC has initiated a nationwide Class I recall for its ELECTRO BUZZ dietary supplement due to undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil. This poses a severe health risk, necessitating immediate action from procurement, regulatory, and supply chain leaders to scrutinize ingredient sourcing and ensure robust compliance frameworks against adulterated products.

REGULATORY INTELLIGENCE
2025-06-18

AvKARE Recalls Celecoxib Capsules Over Tadalafil Cross-Contamination, Highlighting Persistent QC Issues

AvKARE has initiated a Class II recall of Celecoxib Capsules due to Tadalafil cross-contamination, affecting 3,817 cartons nationwide. This incident underscores AvKARE's recurring quality control challenges, including previous mix-ups and impurities. Procurement and regulatory teams must assess supply chain risks and consider alternative suppliers to mitigate potential disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2025-06-11

FDA Initiates Class II Recall for American Health Packaging's Indomethacin ER Capsules Over cGMP Deviations

American Health Packaging has initiated a Class II recall for Indomethacin Extended-Release Capsules, USP, 75 mg, due to cGMP deviations. This voluntary, nationwide recall impacts 21 cartons of Lot #: 1021950, signaling critical manufacturing quality concerns. Procurement and regulatory teams must assess supply chain risks and monitor American Health Packaging's remediation efforts closely.

REGULATORY INTELLIGENCE
2025-06-11

FDA Class II Recall: Consumer Product Partners' Subpotent Ethyl Alcohol Hand Sanitizer Impacts Supply Chain

Consumer Product Partners, LLC has initiated a Class II recall for 125,040 bottles of Spectrum Advanced Gel Hand Sanitizer due to subpotent ethyl alcohol content and cloudy appearance. This voluntary action, impacting nationwide U.S. distribution, underscores critical quality control failures in OTC drug manufacturing. Supply chain and procurement leaders must reassess supplier qualification and product testing protocols to mitigate similar risks.

REGULATORY INTELLIGENCE
2025-06-11

Torrent Pharma Inc. Initiates Class II Recall of Fluoxetine Tablets Due to Nitrosamine Contamination

Torrent Pharma Inc. has initiated a U.S. nationwide Class II recall for 3,672 bottles of Fluoxetine Tablets, USP, 20 mg. The recall, D-0455-2025, stems from Current Good Manufacturing Practice (CGMP) deviations, specifically the presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limits. This event underscores critical supply chain and quality control challenges for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-06-11

Apotex Corp. Initiates Nationwide Recall of Lacosamide Oral Solution Due to Defective Container

Apotex Corp. has initiated a Class II recall for 20,648 bottles of Lacosamide Oral Solution, 10 mg/mL, distributed US Nationwide. The recall, D-0457-2025, stems from defective containers, specifically leaking units when stored horizontally. This event necessitates immediate action from procurement and regulatory teams to assess supply chain integrity and patient safety risks.

REGULATORY INTELLIGENCE
2025-06-04

Glenmark Carvedilol Recall: FDA Cites CGMP Deviations and N-Nitroso Impurity Risk

Glenmark Pharmaceuticals Inc., USA, initiated a Class II recall for Carvedilol Tablets due to CGMP deviations and N-Nitroso Carvedilol I impurity exceeding acceptable limits. This event mandates immediate review of Carvedilol supply chains, highlighting critical regulatory and quality control risks for procurement and regulatory affairs leaders managing cardiovascular drug portfolios.

REGULATORY INTELLIGENCE
2025-06-04

FDA Class I Recall: China-Based EnShiShiXiangNiShangMaoYouXianGongSi's Adulterated Supplement via Amazon

EnShiShiXiangNiShangMaoYouXianGongSi initiated a Class I recall for its 'ENDURANCE BOOST WITH HORNY GOAT WEED' supplement, distributed nationwide via Amazon. The product, originating from China, was found to be tainted with undeclared Sildenafil and Propoxyphenylsildenafil, marketed without FDA approval. This event underscores critical supply chain risks in direct-to-consumer channels, demanding heightened due diligence from procurement and regulatory teams to prevent adulterated products.

REGULATORY INTELLIGENCE
2025-06-04

Alembic Pharmaceuticals' Bromfenac Ophthalmic Solution Recall: Navigating Impurity Failures and US Supply Risk

Alembic Pharmaceuticals Limited has initiated a Class II voluntary recall of specific lots of Bromfenac Ophthalmic Solution 0.09% distributed US nationwide. This action, identified as D-0447-2025, stems from the product failing impurity and degradation specifications. Procurement and regulatory teams must assess supply chain stability for this critical ophthalmic drug, given the potential for product unavailability and the need for alternative sourcing strategies.

REGULATORY INTELLIGENCE
2025-05-28

KENIL HEALTHCARE's Artridon Glucosamine Recalled Over CGMP Failures, Highlighting India Manufacturing Risks

KENIL HEALTHCARE PRIVATE LIMITED initiated a Class II recall (D-0421-2025) for 9,984 tubes of Artridon Glucosamine, a topical analgesic containing menthol and methyl salicylate, due to Current Good Manufacturing Practice (CGMP) deviations at its India facility. This terminated recall highlights persistent quality control risks in overseas manufacturing, necessitating rigorous supplier qualification and ongoing vigilance for procurement and regulatory teams sourcing similar active pharmaceutical ingredients and finished products.

REGULATORY INTELLIGENCE
2025-05-28

FDA Class II Recall: Zydus Pharmaceuticals Recalls Esomeprazole Magnesium Due to Degradation Issues

Zydus Pharmaceuticals (USA) Inc. has initiated a Class II recall of Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg. This voluntary action, prompted by out-of-specification degradation products during stability testing, impacts 22,152 units distributed nationwide. Procurement and regulatory teams must assess supply chain stability and compliance, given the FDA's continued scrutiny of product quality.

REGULATORY INTELLIGENCE
2025-05-28

CareFusion 213's BD ChloraPrep Clear Recalled Nationwide Over Sterility Concerns

CareFusion 213, LLC, a Becton, Dickinson and Co. subsidiary, has initiated a Class II recall for 385,200 applicators of BD ChloraPrep Clear due to potential sterility breaches from open packaging seals. This nationwide U.S. recall, affecting critical preoperative skin preparation, mandates immediate action from procurement and regulatory teams to mitigate patient safety risks and ensure supply chain integrity.

REGULATORY INTELLIGENCE
2025-05-28

KENIL HEALTHCARE Initiates Class II Recall of Fluoride Toothpaste Over CGMP Deviations: Supply Chain Impact for US Distributors

KENIL HEALTHCARE PRIVATE LIMITED has initiated a Class II recall of 150,768 tubes of Nature Mint Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations. This action impacts US distribution in Delaware and North Carolina, managed by Bob Barker Co. Inc. Procurement and regulatory teams must assess immediate supply chain risks and review compliance protocols for contract manufacturers, particularly those in India, to mitigate future disruptions and ensure product quality.

REGULATORY INTELLIGENCE
2025-05-28

AstraZeneca's Airsupra Inhalation Aerosol Faces FDA Class II Recall Over Defective Delivery System

AstraZeneca Pharmaceuticals LP has initiated a voluntary Class II recall (D-0444-2025) for over one million units of Airsupra (albuterol and budesonide) inhalation aerosol due to a defective delivery system. This nationwide U.S. distribution recall, impacting critical respiratory therapy, necessitates immediate supply chain reassessment and robust quality control for combination products.

REGULATORY INTELLIGENCE
2025-05-28

KVK-Tech Initiates Nationwide Class II Recall of Indomethacin ER Capsules Due to cGMP Deviations

KVK-Tech, Inc. has initiated a nationwide Class II recall of 9,107 bottles of Indomethacin Extended-Release Capsules USP, 75 mg, due to cGMP deviations identified at its Newtown, PA facility. This voluntary, firm-initiated action, impacting Lot #18400A, signals critical quality system failures. Procurement and regulatory teams must assess supply chain vulnerabilities for Indomethacin and similar NSAIDs, ensuring robust supplier qualification and continuous monitoring to mitigate disruption risks.

REGULATORY INTELLIGENCE
2025-05-21

L'Oreal USA Initiates Nationwide Recall of La Roche-Posay Effaclar Duo Over Benzene Contamination

L'Oreal USA has initiated a Class II recall of all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots due to detected trace levels of benzene, stemming from cGMP deviations. This nationwide action underscores critical supply chain and regulatory risks for procurement directors and regulatory affairs heads, demanding immediate review of quality control protocols for active pharmaceutical ingredients like Benzoyl Peroxide.

REGULATORY INTELLIGENCE
2025-05-14

FDA Class II Recall: BSO LLC's Testosterone Pellets Contaminated with Glass Particles

BSO LLC has initiated a nationwide Class II recall (D-0412-2025) for 2,762 vials of TESTOSTERONE PELLET 100 mg due to glass particle contamination. This event highlights critical quality control failures at the Lakewood, CO facility, posing significant patient safety risks and immediate supply chain disruptions for healthcare providers relying on this compounded drug. Decision-makers must assess supplier risks and ensure robust quality assurance.

REGULATORY INTELLIGENCE
2025-05-14

Siddha Flower Essences Faces Nationwide Recall of 'temper tamer' Due to CGMP Deviations

Siddha Flower Essences, LLC. has initiated a Class II nationwide recall (D-0410-2025) for its 'temper tamer' Homeopathic Oral Spray due to Current Good Manufacturing Practice (CGMP) deviations. This event signals critical supply chain and regulatory risks for procurement directors and regulatory affairs heads, demanding immediate review of supplier compliance and potential sourcing alternatives to mitigate disruption.

REGULATORY INTELLIGENCE
2025-05-14

FDA Mandates Class II Recall for BRS Analytical Services' Ophthalmic Gel Over cGMP Deviations and Sterility Concerns

BRS Analytical Services, LLC initiated a Class II recall for Carboxymethylcellulose Sodium Ophthalmic Gel 1% due to critical cGMP deviations and sterility assurance failures. This impacts 1,610 cases distributed nationwide, posing significant supply chain and regulatory risks for procurement and regulatory affairs leaders. Immediate action is required to assess supplier compliance and mitigate disruption.

REGULATORY INTELLIGENCE
2025-05-14

FDA Class II Recall: BRS Analytical Services' Lubricant Eye Drops Face Sterility Assurance Failure

BRS Analytical Services, LLC faces a Class II FDA recall (D-0407-2025) for 13,104 cases of Lubricant Eye Drops Solution due to cGMP deviations and sterility assurance failures. This nationwide recall impacts distributors like AvKARE, demanding urgent supply chain adjustments and rigorous quality reviews for all ophthalmic product procurement to mitigate significant business and reputational risks.

REGULATORY INTELLIGENCE
2025-05-07

Nubratori, Inc. Initiates Class II Recall for Dexonto 0.4% Due to Critical Labeling Error

Nubratori, Inc. has initiated a Class II recall for its Dexonto 0.4% (dexamethasone sodium phosphate) solution due to an incorrect expiration date on outer packaging. This voluntary, firm-initiated action impacts 20 boxes distributed in PA and CA, highlighting the critical need for stringent labeling controls to prevent patient safety risks and ensure regulatory compliance.

REGULATORY INTELLIGENCE
2025-05-07

Sandoz Infuvite Adult Recall Highlights Critical Cold Chain Vulnerabilities

Sandoz Inc.'s INFUVITE ADULT, a multiple vitamins injection, is subject to a Class II voluntary recall (D-0401-2025) due to severe thunderstorm-induced transit delays that breached cold chain integrity. This event, initiated by McKesson Medical-Surgical Inc., underscores critical vulnerabilities in pharmaceutical logistics. Procurement and supply chain leaders must reassess third-party logistics providers' resilience and cold chain monitoring protocols to mitigate similar disruptions and protect product quality.

REGULATORY INTELLIGENCE
2025-05-07

FDA Class II Recall: Accord Healthcare's Subpotent Levothyroxine Sodium Tablets Pose Supply Risk

Accord Healthcare Inc. has initiated a Class II recall for subpotent Levothyroxine Sodium Tablets, 88 mcg, manufactured by Intas Pharmaceuticals. This action impacts 4,885 bottles distributed nationwide, raising critical questions for procurement and regulatory teams regarding supply chain integrity and quality control for essential thyroid medication. Decision-makers must assess their sourcing strategies immediately.

REGULATORY INTELLIGENCE
2025-05-07

Preferred Pharmaceuticals Initiates Class II Recall of Clindamycin Hydrochloride Capsules Due to cGMP Deviations

Preferred Pharmaceuticals, Inc. has initiated a Class II recall for 1,190 bottles of Clindamycin Hydrochloride Capsules, USP, 300mg, manufactured by Glenmark Pharmaceuticals Limited. This nationwide US recall, stemming from cGMP deviations, necessitates immediate action from procurement and regulatory teams to assess supply chain integrity and ensure patient safety. The ongoing status highlights persistent compliance challenges within the pharmaceutical sector.

REGULATORY INTELLIGENCE
2025-05-07

FDA Class II Recall: Eugia US LLC's Tirofiban Hydrochloride Injection Faces Quality Scrutiny

Eugia US LLC has initiated a Class II nationwide recall for 18,867 bags of Tirofiban Hydrochloride Injection due to out-of-specification results in stability studies for related substances. This event signals critical quality control deficiencies impacting a key cardiovascular drug. Procurement and regulatory teams must assess immediate supply chain risks and re-evaluate supplier qualification protocols to mitigate disruption and ensure patient safety.

REGULATORY INTELLIGENCE
2025-04-30

Breckenridge Pharmaceutical Recalls Duloxetine 60 mg Over Nitrosamine Impurity: Supply Chain Impact

Breckenridge Pharmaceutical has initiated a Class II recall for 16,473 bottles of Duloxetine Delayed-Release Capsules, 60 mg, distributed nationwide. This action, stemming from CGMP deviations, addresses nitrosamine impurities exceeding interim limits. Procurement and regulatory teams must assess supply chain exposure and reinforce quality assurance protocols for generic antidepressants to mitigate disruption and ensure compliance.

REGULATORY INTELLIGENCE
2025-04-30

Pharmadel LLC's Kingskin Salicylic Acid Recall Signals cGMP Compliance Gaps for OTC Market

Pharmadel LLC initiated a Class II recall (D-0381-2025) for 20,048 bottles of Kingskin (Salicylic Acid) due to cGMP deviations from its New Castle, DE facility. This event, terminated on January 8, 2026, highlights critical compliance risks for procurement and regulatory teams sourcing OTC topical drugs. Businesses must reassess supplier due diligence and ensure robust quality agreements to mitigate supply chain disruptions from similar regulatory actions.

REGULATORY INTELLIGENCE
2025-04-30

FDA Initiates Class II Recall of Apipharma's Hemopropin Ointment Over CGMP Deviations from Croatian Facility

Apipharma faces an FDA Class II recall for 4,218 boxes of Hemopropin Ointment, citing Current Good Manufacturing Practice (CGMP) deviations at its Zagreb, Croatia facility. This action, initiated by the firm, highlights critical quality control failures, posing significant supply chain and regulatory compliance challenges for global procurement and regulatory affairs teams sourcing similar topical formulations.

REGULATORY INTELLIGENCE
2025-04-30

Leiters Health Rocuronium Bromide Recall: Sterility Failure Poses High Supply Chain Risk

Denver Solutions, LLC DBA Leiters Health has initiated a Class II recall for 16,655 syringes of Rocuronium Bromide due to sterility assurance issues, specifically leaking/damaged syringes. This nationwide recall, impacting Lot #:2530023, Exp.: 7/12/2025, necessitates immediate action from procurement and regulatory teams to mitigate supply chain disruptions and ensure patient safety with this critical neuromuscular blocker.

REGULATORY INTELLIGENCE
2025-04-30

FDA Class II Recall: BluePoint Laboratories' Haloperidol Decanoate Injection Faces Sterility Concerns

BluePoint Laboratories faces an FDA Class II recall of 14,189 vials of Haloperidol Decanoate Injection, 100 mg/mL, due to bacterial contamination from its manufacturer, Somerset Therapeutics Limited in India. This nationwide recall, D-0368-2025, demands immediate action from procurement and regulatory teams to secure alternative supplies and assess supply chain vulnerabilities for this critical Central Nervous System drug.

REGULATORY INTELLIGENCE
2025-04-30

OurPharma LLC Terminates Class III Recall for Superpotent HYDROmorphone HCl

OurPharma LLC has concluded a Class III voluntary recall (D-0385-2025) for 1,375 cassettes of superpotent HYDROmorphone Hydrochloride 50mg/50mL, manufactured at its Fayetteville, AR facility. This event, initiated April 15, 2025, and terminated March 6, 2026, highlights critical quality control vulnerabilities in compounded sterile products. Procurement and regulatory teams must scrutinize supplier potency testing protocols to mitigate supply chain risks.

REGULATORY INTELLIGENCE
2025-04-30

Lupin Pharmaceuticals' Clomipramine Hydrochloride Capsules Recalled Over Degradation Failures

Lupin Pharmaceuticals Inc. has concluded a Class II nationwide recall (D-0377-2025) for Clomipramine Hydrochloride Capsules USP, 25 mg, due to out-of-specification degradation products identified during an 18-month stability study. This event underscores critical quality control vigilance for generic psychiatric medications, impacting supply chain stability and regulatory compliance for procurement and regulatory affairs teams.

REGULATORY INTELLIGENCE
2025-04-23

FDA Class II Recall: Eugia US LLC's Testosterone Cypionate Injection Raises cGMP Concerns

Eugia US LLC has initiated a Class II recall for 36,816 vials of Testosterone Cypionate Injection, USP, CIII, due to crystallization issues, indicating potential cGMP violations. This voluntary, firm-initiated action impacts nationwide U.S. distribution, necessitating immediate supply chain review and robust quality assurance protocols for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-04-16

Asegua Therapeutics Initiates Class II Recall of Sofosbuvir and Velpatasvir Due to Packaging Defects

Asegua Therapeutics LLC, an affiliate of Gilead Sciences, faces a Class II FDA recall for 18,541 cartons of Sofosbuvir and Velpatasvir tablets. The issue stems from defective blister pack seals, causing loose tablets. This event necessitates immediate action for procurement, regulatory, and supply chain leaders to assess inventory, ensure patient safety, and review quality oversight for internationally manufactured critical medications.

REGULATORY INTELLIGENCE
2025-04-16

Sun Pharma's Gabapentin Recall Due to Cross-Contamination Highlights Persistent Quality Risks

Sun Pharmaceutical Industries Inc. has initiated a Class III recall of 12,876 bottles of Gabapentin Capsules, USP 300 mg, distributed nationwide in the USA, due to cross-contamination. This event, originating from their Halol, India manufacturing site, underscores persistent quality control challenges for Sun Pharma, impacting supply chain reliability. Procurement and regulatory teams must reassess supplier risk and contingency plans.

REGULATORY INTELLIGENCE
2025-04-16

FDA Class II Recall: Glenmark's Ranolazine Tablets Impacted by CGMP Deviations, Raising Supply Chain Concerns

Glenmark Pharmaceuticals Inc., USA has initiated a Class II recall (D-0335-2025) for Ranolazine Extended-Release Tablets 1000mg nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This action, impacting lot 17240040, signals critical quality control deficiencies at the manufacturing site in Pithampur, India. Procurement and regulatory teams must assess supply chain risks and evaluate alternative Ranolazine sources to ensure continuity and compliance.

REGULATORY INTELLIGENCE
2025-04-16

Alchemee, LLC Initiates Class II Recall for Benzene-Contaminated Proactiv Skin Smoothing Exfoliator

Alchemee, LLC has initiated a Class II recall for 3,500 bottles of Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%) due to benzene contamination. This voluntary, nationwide recall highlights critical quality control gaps in topical drug manufacturing, demanding immediate action from procurement and regulatory teams to mitigate supply chain risks and protect brand integrity.

REGULATORY INTELLIGENCE
2025-04-16

FDA Class II Recall: Zydus Pharmaceuticals' Chlorpromazine Hydrochloride Impacted by Nitrosamine Impurity

Zydus Pharmaceuticals (USA) Inc. has initiated a Class II recall (D-0361-2025) for Chlorpromazine Hydrochloride Tablets, USP 10 mg, distributed nationwide across the U.S. This voluntary action stems from CGMP deviations, specifically the presence of N-Nitroso-Desmethyl Chlorpromazine impurity exceeding interim limits. This event mandates immediate review of supply chain resilience for Chlorpromazine Hydrochloride and highlights the persistent risk of nitrosamine contamination in pharmaceutical manufacturing, impacting procurement and regulatory strategies.

REGULATORY INTELLIGENCE
2025-04-16

FDA Class II Recall: Somerset Therapeutics' Haloperidol Decanoate Injection Fails Sterility Assurance

Somerset Therapeutics, LLC faces significant regulatory scrutiny following a Class II recall of Haloperidol Decanoate Injection due to sterility assurance failures. This voluntary, firm-initiated recall of 240 vials distributed U.S. nationwide highlights critical manufacturing control deficiencies at its Bengaluru, India facility. Procurement and regulatory teams must assess supply chain risks and prepare for potential market disruptions for this antipsychotic medication.

REGULATORY INTELLIGENCE
2025-04-16

B. Braun Medical Inc. Initiates Class II Recall of Sodium Chloride Irrigation Due to Particulate Matter

B. Braun Medical Inc. has initiated a voluntary Class II recall of 32,256 bottles of 0.9% Sodium Chloride Irrigation USP due to particulate matter. This event, identified as D-0353-2025, impacts nationwide distribution, necessitating immediate action from procurement and supply chain leaders to quarantine affected lots and secure alternative sourcing for this critical medical product.

REGULATORY INTELLIGENCE
2025-04-16

Glenmark Pharmaceuticals Recalls Diltiazem Hydrochloride Due to CGMP Deviations: U.S. Supply Chain Impact

Glenmark Pharmaceuticals Inc., USA has initiated a U.S. nationwide Class II recall for specific lots of Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg due to Current Good Manufacturing Practice (CGMP) deviations at its Indian manufacturing facility. This event necessitates immediate action for procurement and supply chain leaders to assess inventory, ensure compliance, and mitigate potential supply disruptions for this critical cardiovascular medication.

REGULATORY INTELLIGENCE
2025-04-09

American Health Packaging's Voriconazole Recall: cGMP Deviations in Repackaging Trigger Nationwide Class II Action

American Health Packaging initiated a Class II recall for Voriconazole Tablets 50 mg due to cGMP deviations in repackaging. This event, now terminated, highlights critical vulnerabilities in outsourced pharmaceutical handling. Procurement and regulatory teams must reinforce due diligence for repackaging partners to mitigate supply chain risks and ensure product integrity, impacting nationwide distribution.

REGULATORY INTELLIGENCE
2025-04-09

Glenmark Pharmaceuticals Recalls Chlorpromazine Hydrochloride Tablets Over Nitrosamine Impurity

Glenmark Pharmaceuticals Inc., USA initiated a Class II recall of 8,160 bottles of Chlorpromazine Hydrochloride Tablets, USP 100 mg, due to N-Nitroso-Desmethyl Chlorpromazine impurity exceeding interim limits. This voluntary recall, stemming from CGMP deviations, impacts nationwide U.S. and Puerto Rico distribution. Procurement and regulatory teams must assess supply chain stability and evaluate alternative generic antipsychotic sources to mitigate disruption.

REGULATORY INTELLIGENCE
2025-04-09

Major Pharmaceuticals Recalls Tolterodine Tartrate Extended-Release Capsules Due to Dissolution Failure

The Harvard Drug Group LLC, operating as Major Pharmaceuticals, initiated a Class III recall for Tolterodine Tartrate Extended-Release Capsules due to failed dissolution specifications identified during routine stability testing. This voluntary recall, affecting 224 cartons nationwide, highlights critical quality control vulnerabilities in generic drug manufacturing. Procurement and regulatory teams must scrutinize supplier stability data to mitigate supply chain disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2025-04-09

Biocon Pharma Inc. Initiates Class II Recall for Atorvastatin Calcium Due to Dissolution Failure

Biocon Pharma Inc. has initiated a Class II recall for Atorvastatin Calcium Tablets USP 40 mg across the U.S. due to failed dissolution specifications. This impacts 2184 bottles (1000-count) from lot AVC24035, manufactured by Recipharm Pharmaservices PVT, Ltd in India. Procurement teams must secure alternative sources, while regulatory affairs must ensure robust CAPA to maintain market access.

REGULATORY INTELLIGENCE
2025-04-09

Breckenridge Pharmaceutical Initiates Nationwide Duloxetine Recall Over Nitrosamine Impurity

Breckenridge Pharmaceutical has initiated a nationwide Class II recall of Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine, an NDSRI, exceeding interim limits. This voluntary action impacts 14,863 bottles, signaling critical CGMP deviations. Procurement and regulatory teams must assess supply chain vulnerabilities and enhance impurity testing protocols to mitigate future risks.

REGULATORY INTELLIGENCE
2025-04-02

Ascent Consumer Products Inc. Initiates Class I Recall of SinuCleanse Nasal Wash Due to Staphylococcus aureus Contamination

Ascent Consumer Products Inc. has initiated a Class I recall for its SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System due to bacterial contamination with *Staphylococcus aureus*. This event, impacting 4,176 cartons nationwide, signals critical supply chain and regulatory risks. Procurement and regulatory affairs teams must immediately assess inventory, potential stock-outs, and review supplier quality protocols to mitigate exposure.

REGULATORY INTELLIGENCE
2025-04-02

FDA Class II Recall: A-S Medication Solutions' Metformin HCl ER Contaminated with Foreign Tablets

A-S Medication Solutions LLC initiated a Class II recall for 411 bottles of Metformin Hydrochloride Extended-Release 500mg due to foreign tablets/capsules. This voluntary action, impacting nationwide U.S. distribution, signals critical quality control gaps for procurement and regulatory teams. Businesses must assess their supply chain exposure to A-S Medication Solutions and verify product integrity to mitigate patient safety risks and ensure compliance.

REGULATORY INTELLIGENCE
2025-04-02

Exela Pharma Sciences Recalls 103,950 Vials of Sodium Bicarbonate Injection Due to Sterility Concerns

Exela Pharma Sciences LLC has initiated a Class II recall of 103,950 vials of 8.4% Sodium Bicarbonate Injection, USP, due to a lack of sterility assurance. This nationwide recall, impacting critical intravenous medication, necessitates immediate action from procurement, supply chain, and regulatory teams to mitigate patient risk and ensure continuity of supply.

REGULATORY INTELLIGENCE
2025-04-02

Johnson, S C and Son Initiates Class II Recall of babyganics Zinc Oxide Sunscreen Due to Stability Failures

Johnson, S C and Son, Inc. has initiated a Class II recall of 57,184 bottles of babyganics Sheer Blend SPF 50 Mineral Sunscreen (zinc oxide 20%) due to failed stability specifications, specifically physical ingredient separation. This event underscores critical quality control and supply chain oversight challenges for procurement and regulatory teams, particularly for products manufactured internationally, demanding immediate review of supplier qualification and stability testing protocols.

REGULATORY INTELLIGENCE
2025-04-02

QuVa Pharma Faces FDA Class II Recall for Sterility Issues in Compounded Fentanyl/Bupivacaine Injectable

QuVa Pharma, Inc. has initiated a U.S. nationwide Class II recall for 2,310 cassettes of its compounded fentaNYL Citrate PF / Bupivacaine HCl injection from its Sugar Land, TX facility. The recall, effective March 6, 2025, stems from a critical lack of assurance of sterility, posing significant patient safety risks and demanding immediate attention from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-03-26

FDC Limited Faces Fifth Ophthalmic Recall: Ciprofloxacin Solution Impacted by Recurring Container Defects

FDC Limited has initiated a Class II recall (D-0282-2025) for 90,960 bottles of Ciprofloxacin Ophthalmic Solution USP, 0.3%, due to defective containers. This marks the fifth ophthalmic product recall for FDC Limited since May 2024, signaling persistent quality control issues at its Aurangabad, India facility and posing significant supply chain risks for U.S. distributors like Leading Pharma LLC.

REGULATORY INTELLIGENCE
2025-03-26

Medline Industries Recalls 1.6 Million Subpotent CURAD Alcohol Prep Pads: Critical Supply Chain and Quality Implications

Medline Industries, LP has initiated a voluntary Class II recall of 1,639,996 CURAD Alcohol Prep Pads due to subpotency. This nationwide recall of the Isopropyl Alcohol OTC drug, manufactured in India, highlights critical supply chain and quality control vulnerabilities. Procurement, regulatory, and supply chain leaders must assess current inventory, diversify sourcing for topical antiseptics, and reinforce stringent oversight of international contract manufacturers to mitigate patient safety risks and ensure product efficacy.

REGULATORY INTELLIGENCE
2025-03-26

Rising Pharma Recalls Duloxetine Due to N-nitroso-duloxetine Impurity: Commercial and Regulatory Impact

Rising Pharma Holding, Inc. initiated a Class II recall of 1,223 bottles of Duloxetine Delayed-Release Capsules, 30 mg, nationwide in the USA. This action, D-0277-2025, stems from CGMP deviations, specifically N-nitroso-duloxetine impurity exceeding interim limits. Procurement and regulatory teams must assess supplier quality controls and potential supply chain vulnerabilities for Duloxetine.

REGULATORY INTELLIGENCE
2025-03-26

Mylan Pharmaceuticals Initiates Nationwide Recall of Prasugrel Tablets Due to Dissolution Failure

Mylan Pharmaceuticals Inc. has initiated a voluntary Class II recall of Prasugrel Tablets, USP, 5 mg, distributed nationwide, due to failed dissolution specifications. This event, originating from their Morgantown, WV facility, signifies potential efficacy concerns for this critical antiplatelet drug. Procurement and supply chain leaders must assess immediate sourcing risks and monitor Mylan's corrective actions to mitigate future supply disruptions.

REGULATORY INTELLIGENCE
2025-03-26

Amgen's Neupogen Filgrastim Recall: Global Supply Chain Implications Due to Stability Issues

Amgen, Inc. has initiated a Class II recall for 313,620 vials of Neupogen (filgrastim) globally, citing stability data that fails to support the product's 36-month expiry. This voluntary action, impacting diverse markets from the U.S. to Europe and Asia, poses significant supply chain risks for procurement and regulatory teams reliant on Amgen's leukocyte growth factor. Stakeholders must assess inventory and explore alternative filgrastim sources to mitigate potential disruptions.

REGULATORY INTELLIGENCE
2025-03-26

Mylan Institutional Recalls Super-Potent Levothyroxine Sodium Tablets Nationwide Due to Potency Deviations

Mylan Institutional Inc. has initiated a Class II recall for Levothyroxine Sodium Tablets due to super-potent, out-of-specification results. This impacts procurement and regulatory teams, necessitating immediate review of inventory and supply chain integrity for this critical thyroid medication. The voluntary recall, affecting 1,068 cartons, highlights ongoing quality control challenges in pharmaceutical manufacturing.

REGULATORY INTELLIGENCE
2025-03-26

FDA Issues Class I Recall for One Source Nutrition's Vitality Product Amid Undeclared Sildenafil and Tadalafil Contamination

One Source Nutrition, Inc. faces a Class I FDA recall (D-0281-2025) for its "Vitality" male enhancement product, tainted with undeclared sildenafil and tadalafil. This nationwide U.S. recall underscores critical regulatory and quality control failures, posing significant risks to consumer health and demanding immediate action from supply chain partners to assess product integrity and ensure compliance with drug approval standards.

REGULATORY INTELLIGENCE
2025-03-26

Golden State Medical Supply Inc. Initiates Class II Recall of Prasugrel Tablets Over Failed Dissolution

Golden State Medical Supply Inc. has initiated a U.S. nationwide Class II recall for 2,601 bottles of PRASUGREL TABLETS, 5 mg, due to failed dissolution specifications. This voluntary action, impacting multiple lots, signals critical quality control deficiencies. Procurement and regulatory teams must assess immediate supply chain risks for this antiplatelet medication and reinforce supplier qualification protocols to mitigate future disruptions and ensure product efficacy.

REGULATORY INTELLIGENCE
2025-03-19

FDA Class II Recall: Johnson, S C and Son, Inc. Sunscreen Contamination Prompts Market Withdrawal

Johnson, S C and Son, Inc. has initiated a Class II recall of 493,462 units of Kids by babyganics SPF 50 mineral sunscreen due to chemical contamination. This voluntary action, impacting US and Canadian markets, necessitates immediate review by procurement and regulatory teams. The event underscores critical supply chain vigilance for OTC drug products, particularly those with active ingredients like titanium dioxide and zinc oxide.

REGULATORY INTELLIGENCE
2025-03-19

FDA Class II Recall: Aspen Biopharma Labs' Alprostadil API Faces CGMP Scrutiny in India

Aspen Biopharma Labs Pvt., Ltd. faces an FDA Class II recall (D-0261-2025) for its Alprostadil API, initiated February 7, 2025, due to Current Good Manufacturing Practice (CGMP) deviations at its Medchal Malkajgiri, India facility. This voluntary recall impacts three distributors in Hong Kong and Florida, necessitating immediate supply chain risk assessment for procurement and regulatory teams reliant on this critical molecule.

REGULATORY INTELLIGENCE
2025-03-19

FDA Mandates Class II Recall for Chattem Inc's Unisom SleepMelts Due to Nitrosamine Impurity

Chattem Inc initiated a Class II recall for 180,696 cartons of Unisom SleepMelts (Diphenhydramine HCl tablets) due to nitrosamine impurities exceeding FDA limits, stemming from CGMP deviations at manufacturer Adare Pharmaceuticals, Inc. This nationwide USA recall underscores critical supply chain vulnerabilities and heightened regulatory scrutiny on nitrosamine control, demanding immediate action from procurement and regulatory affairs to reassess supplier compliance and product quality.

REGULATORY INTELLIGENCE
2025-03-19

Denison Pharmaceuticals Recalls 642,131 Tubes of Zapzyt Acne Gel Due to Benzene Contamination: A Critical Supply Chain Alert

Denison Pharmaceuticals, LLC has initiated a Class II recall of 642,131 tubes of Zapzyt Acne Treatment Gel, 10% benzoyl peroxide, due to benzene contamination. This nationwide recall, D-0273-2025, highlights critical vulnerabilities in raw material sourcing and manufacturing quality control. Procurement and regulatory teams must immediately reassess their supply chains for similar risks in topical OTC products.

REGULATORY INTELLIGENCE
2025-03-19

Breckenridge Pharmaceutical Initiates Class II Recall of Duloxetine Due to N-Nitroso Impurity

Breckenridge Pharmaceutical, Inc. has initiated a Class II recall of 14,749 bottles of Duloxetine Delayed-Release Capsules, USP, 30mg, due to N-nitroso-duloxetine impurity exceeding FDA limits. This event, stemming from CGMP deviations at manufacturer Towa Pharmaceutical Europe, S.L., necessitates immediate supply chain reassessment for procurement and regulatory teams, highlighting critical quality control vulnerabilities.

REGULATORY INTELLIGENCE
2025-03-19

ICU Medical Initiates Class I Recall for Potassium Chloride Injection Due to Critical Labeling Error

ICU Medical, Inc. has initiated a Class I recall (D-0268-2025) for its Potassium Chloride Injection due to a critical labeling error where 10 mEq overwraps may contain 20 mEq containers. This poses a severe patient safety risk, demanding immediate action from procurement, supply chain, and regulatory teams to assess inventory and ensure compliance.

REGULATORY INTELLIGENCE
2025-03-19

Kowa Pharmaceuticals America Initiates Class III Recall for Livalo (Pitavastatin Calcium) Due to Foreign Material

Kowa Pharmaceuticals America, Inc. has completed a Class III recall of 5,328 bottles of Livalo (Pitavastatin Calcium) 4 mg tablets due to foreign tablets/capsules. This voluntary action, impacting distribution in PA, OH, and TX, underscores critical quality control vulnerabilities for procurement and regulatory teams managing cardiovascular drug supply chains.

REGULATORY INTELLIGENCE
2025-03-19

Sigan Industries Group Inc. Initiates Class II Recall of Walgreens Acne Cleanser Due to Benzene Contamination

Sigan Industries Group Inc. has initiated a Class II recall of 13,440 tubes of Walgreens Acne Control Cleanser (10% Benzoyl Peroxide) due to benzene contamination. This Canadian-based manufacturer's action impacts U.S. nationwide distribution. Procurement and regulatory teams must assess immediate supply chain risks and review quality protocols for outsourced OTC products.

REGULATORY INTELLIGENCE
2025-03-19

CareFusion 213, LLC Initiates Class I Recall of ChloraPrep Applicators Due to Non-Sterility

CareFusion 213, LLC has initiated a Class I recall of 205,440 BD ChloraPrep Clear 1mL Applicators due to Aspergillus penicillioides contamination from package lidding breach. This poses a severe patient safety risk, demanding immediate action from procurement and supply chain leaders to secure alternative sterile preoperative skin preparations and reassess supplier quality protocols for critical medical supplies.

REGULATORY INTELLIGENCE
2025-03-19

FDA Class I Recall: Central Admixture Pharmacy Services' PHENYLephrine Contamination Poses Nationwide Risk

Central Admixture Pharmacy Services, Inc. initiated a Class I recall for 1,546 bags of PHENYLephrine due to particulate matter, distributed nationwide. This poses a critical patient safety risk and immediate supply chain challenge for healthcare providers. Procurement and regulatory teams must assess current inventory and diversify sourcing for this essential vasopressor.

REGULATORY INTELLIGENCE
2025-03-19

FDA Class II Recall: Nephron Sterile Compounding's Sodium Chloride Injection 9% Due to Sterility Concerns

Nephron Sterile Compounding Center LLC initiated a Class II recall for 4,190 bottles of Sodium Chloride Injection 9%, USP, 500 mL, due to potential IV bottle port leakage compromising sterility. This voluntary, firm-initiated recall, D-0257-2025, impacts US nationwide distribution. For procurement and regulatory teams, this highlights critical supplier quality vigilance, especially for 503B outsourcing facilities providing sterile injectables. The recall was terminated on August 14, 2025.

CLINICAL & PIPELINE
2025-03-14

FDA Approves Latest Labeling Update for NDA 018890: Implications for Lifecycle Management

The FDA has approved the latest labeling supplement (SUPPL 58) for NDA 018890 on March 14, 2025, marking another routine update for this long-standing pharmaceutical product. This event underscores the continuous regulatory oversight required for mature assets, impacting regulatory affairs, supply chain, and business development strategies for global chemical and life sciences firms.

REGULATORY INTELLIGENCE
2025-03-12

Safecor Health Recalls 1,535 Ferrous Sulfate Oral Syringes Due to Defective Delivery System Leakage

Safecor Health, LLC, initiated a Class II recall for 1,535 units of Ferrous Sulfate 7.5 mg Oral Syringes due to leakage from a defective delivery system. This nationwide recall, D-0252-2025, highlights critical quality control issues in pharmaceutical repackaging. Procurement and regulatory teams must assess supply chain risks and ensure robust packaging integrity protocols to mitigate patient safety concerns.

REGULATORY INTELLIGENCE
2025-03-12

FDA Class II Recall: Sun Pharma's Morphine Sulfate ER Tablets Fail Dissolution Specifications

Sun Pharmaceutical Industries, Inc. faces an FDA Class II recall for 9,840 bottles of Morphine Sulfate Extended-Release Tablets, 100 mg, due to failed dissolution specifications. This voluntary action, initiated February 6, 2025, highlights critical quality control risks for opioid analgesics manufactured by Ohm Laboratories Inc. Procurement and regulatory teams must assess supply chain exposure and reinforce stringent supplier qualification to mitigate patient safety and market disruption risks.

REGULATORY INTELLIGENCE
2025-03-12

Zydus Pharmaceuticals Recalls Nelarabine Injection Nationwide Over Impurity Failures: Critical Supply Chain Impact

Zydus Pharmaceuticals USA Inc. has initiated a nationwide Class II recall (D-0256-2025) for 1,893 vials of Nelarabine Injection due to failed impurity/degradation specifications. This voluntary action, impacting critical oncology supply, necessitates immediate assessment by procurement and regulatory teams. Businesses must evaluate supply chain resilience and enhance quality assurance protocols to mitigate risks from such product quality deviations.

REGULATORY INTELLIGENCE
2025-03-05

FDA Class II Recall: Turbare Manufacturing's Avastin Repackaging Fails Sterility Assurance

Turbare Manufacturing initiated a Class II recall for 1,147 syringes of repackaged Avastin 1.25 mg/0.05 mL due to a critical lack of sterility assurance from a quality control process deviation. This event underscores significant supply chain and regulatory risks for procurement and regulatory affairs teams sourcing sterile injectable products, demanding immediate review of supplier qualification protocols.

REGULATORY INTELLIGENCE
2025-03-05

FDA Initiates Class II Recall for Wuxi Medical Instrument Factory's ViaMed Alcohol Prep Pads Due to Sterility Concerns

Wuxi Medical Instrument Factory Co., Ltd. faces an FDA Class II recall for ViaMed Alcohol Prep Pads due to sterility assurance failures and cGMP deviations. This impacts Rece International Corp. and necessitates immediate supply chain review for sterile medical devices. Procurement and regulatory teams must assess exposure and reinforce supplier qualification protocols to mitigate risk.

REGULATORY INTELLIGENCE
2025-02-26

FDA Class II Recall: Glenmark's Atomoxetine Capsules Tainted by Nitrosamine Impurity

Glenmark Pharmaceuticals Inc., USA has initiated a Class II recall of 133,824 bottles of Atomoxetine Capsules, USP, 25 mg, due to N-Nitroso Atomoxetine Impurity exceeding FDA limits. This voluntary recall, impacting U.S. nationwide distribution, signals critical CGMP deviations at the manufacturing facility, Glenmark Pharmaceuticals Ltd., Goa, India, posing significant supply chain and regulatory risks for procurement and regulatory affairs teams.

REGULATORY INTELLIGENCE
2025-02-26

FDA Class II Recall: Glenmark's Atomoxetine Capsules Impacted by N-Nitroso Impurity Above Limit

Glenmark Pharmaceuticals Inc., USA, has initiated a Class II recall for 58,368 bottles of Atomoxetine Capsules, USP, 100 mg, due to N-Nitroso Atomoxetine Impurity exceeding FDA limits. This event, stemming from CGMP deviations at Glenmark's Goa, India, manufacturing facility, poses significant supply chain risks for Northstar Rx LLC and procurement teams, necessitating urgent evaluation of alternative suppliers for this ADHD medication.

REGULATORY INTELLIGENCE
2025-02-26

FDA Mandates Class II Recall for Major Pharmaceuticals' Sub-Potent Lorazepam: Critical Supply Chain and Regulatory Implications

The Harvard Drug Group LLC dba Major Pharmaceuticals initiated a Class II recall of Lorazepam Tablets, USP, 0.5mg, due to sub-potency and impurity failures. This event highlights critical quality control gaps within the pharmaceutical supply chain, demanding immediate action from procurement and regulatory teams to ensure supply continuity and patient safety for this essential benzodiazepine.

REGULATORY INTELLIGENCE
2025-02-26

Provepharm Inc. Faces Class I Recall of Phenylephrine HCl Injection Over Particulate Matter, Raising Supply Chain Concerns

Provepharm Inc. has initiated a Class I recall of 24,640 vials of Phenylephrine HCl Injection across the U.S. due to particulate matter, posing severe patient safety risks. This marks Provepharm's second recall in recent months, signaling potential systemic quality control deficiencies. Procurement and regulatory teams must immediately assess their supply chain exposure and review Provepharm's quality assurance processes for critical injectable products.

REGULATORY INTELLIGENCE
2025-02-26

Alvogen Initiates Class I Recall of Fentanyl Transdermal System Due to Defective Delivery System

Alvogen, Inc. has initiated a Class I recall (D-0245-2025) for 112,128 cartons of Fentanyl Transdermal System CII, 25mcg/h, due to a defective delivery system. Patches manufactured by Kindeva Drug Delivery L/P may be multi-stacked in pouches, posing a severe patient safety risk. This nationwide recall demands immediate attention from procurement and regulatory teams to manage supply chain disruptions for this critical opioid.

REGULATORY INTELLIGENCE
2025-02-26

Glenmark Pharmaceuticals Initiates Class II Recall of Atomoxetine Due to N-Nitroso Impurity

Glenmark Pharmaceuticals Inc., USA has initiated a Class II recall (D-0235-2025) for 80,160 bottles of Atomoxetine Capsules, USP, 60 mg, nationwide. This voluntary action stems from Current Good Manufacturing Practice (CGMP) deviations, specifically N-Nitroso Atomoxetine Impurity exceeding FDA limits. Procurement and regulatory teams must assess supply chain risks and compliance protocols, especially for products sourced globally and susceptible to nitrosamine contamination.

REGULATORY INTELLIGENCE
2025-02-12

PAI Holdings Recalls Superpotent Guaifenesin and Codeine Phosphate Oral Solution: Supply Chain and Regulatory Implications

PAI Holdings, LLC initiated a Class III recall of 4,080 bottles of Guaifenesin and Codeine Phosphate Oral Solution due to superpotency and sodium benzoate preservative issues. This event underscores critical quality control vulnerabilities in OTC drug manufacturing. Procurement and regulatory teams must scrutinize supplier quality systems, especially for controlled substances, to mitigate supply chain risks and ensure patient safety.

REGULATORY INTELLIGENCE
2025-02-12

FDA Class II Recall: Glenmark's Carvedilol Tablets Hit by Nitrosamine Impurity

Glenmark Pharmaceuticals Inc., USA has initiated a Class II recall for multiple lots of its Carvedilol Tablets, USP, 12.5 mg, distributed nationwide. The action, D-0216-2025, stems from Current Good Manufacturing Practice (CGMP) deviations, specifically the presence of N-Nitroso Carvedilol I (NNCI-I) impurity exceeding FDA-recommended limits. This voluntary recall highlights critical nitrosamine contamination risks, demanding immediate attention from procurement, regulatory, and supply chain leaders to assess inventory and supplier qualification.

REGULATORY INTELLIGENCE
2025-02-12

FDA Class II Recall: Teva's Granix (tbo-filgrastim) Pulled Due to Stability Failure

Teva Pharmaceuticals USA, Inc. initiated a Class II recall of 34,636 cartons of Granix (tbo-filgrastim) Injection due to failed 12-month stability tests, with a known peptide below specification limits. This voluntary, nationwide recall impacts supply chains for a critical leukocyte growth factor, necessitating immediate action from procurement and regulatory teams to manage disruption and ensure patient safety.

REGULATORY INTELLIGENCE
2025-02-05

Astellas Pharma US Initiates Class I Recall for PROGRAF (Tacrolimus) Capsules Over Empty Capsule Defect

Astellas Pharma US, Inc. has initiated a Class I recall for PROGRAF (tacrolimus) capsules due to bottles potentially containing empty capsules. This critical defect poses significant patient safety risks for transplant recipients, necessitating immediate action from procurement and regulatory teams. The nationwide distribution of this essential immunosuppressant highlights supply chain vulnerabilities and demands a swift, comprehensive response from Astellas.

REGULATORY INTELLIGENCE
2025-02-05

FDA Recalls The W.S. Badger Company's Mineral Sunscreen Over Critical Labeling Deficiencies

The W.S. Badger Company, Inc. faced a Class III FDA recall for its BADGER 50 Mineral Sunscreen due to missing drug facts panels and usage directions. This event, now terminated, underscores critical compliance risks for OTC products. Decision-makers must reinforce labeling quality control to prevent market disruptions and ensure regulatory adherence, especially for zinc oxide formulations.

REGULATORY INTELLIGENCE
2025-02-05

FDA Recall of Duloxetine by The Harvard Drug Group LLC Highlights Critical Nitrosamine Control Failures

The Harvard Drug Group LLC's recall of Duloxetine Delayed-Release Capsules due to N-Nitroso-Duloxetine exceeding FDA limits signals critical CGMP deviations. This event mandates immediate supply chain re-evaluation for procurement and regulatory teams, underscoring persistent nitrosamine risks and the need for enhanced quality oversight for all distributed pharmaceuticals.

REGULATORY INTELLIGENCE
2025-02-05

FDA Class II Recall: Inadvertent Distribution of Pfizer-Distributed Inflectra (Infliximab-dyyb) Due to cGMP Deviation

McKesson initiated a Class II recall (D-0213-2025) for 192 vials of Pfizer-distributed Inflectra (infliximab-dyyb) due to cGMP deviations, specifically inadvertent distribution of quarantined product. This event highlights critical vulnerabilities in supply chain quality control and segregation protocols, demanding immediate attention from procurement and regulatory teams to assess internal and partner compliance.

REGULATORY INTELLIGENCE
2025-01-29

FDA Class II Recall: Brands International Corporation's Diabetics Foot Cream Pulled Over Critical CGMP Deviations

Brands International Corporation has initiated a Class II recall of its Kissable Diabetics Foot Cream due to critical CGMP deviations, specifically inadequate release testing. This impacts nationwide USA distribution, necessitating immediate action for procurement and supply chain leaders to assess inventory, manage logistics, and ensure product quality amidst heightened FDA scrutiny on manufacturing compliance.

REGULATORY INTELLIGENCE
2025-01-29

Appco Pharma's Venlafaxine Recall Signals Recurring Quality Control Challenges

Appco Pharma LLC initiated a Class III recall for 1,380 bottles of Venlafaxine Extended-Release Tablets due to missing tablet identification. This event, following a 2020 Class II Ranitidine recall, highlights recurring quality control issues. Procurement and regulatory teams must assess supplier risk and explore alternative sources for Venlafaxine Hydrochloride to ensure supply chain resilience.

REGULATORY INTELLIGENCE
2025-01-22

Akron Pharma Initiates Class III Recall of Diphenhydramine HCl 25 mg Capsules Due to Labeling Errors

Akron Pharma, Inc. has initiated a voluntary Class III recall of 456 bottles of Diphenhydramine HCl 25 mg capsules (Lot KDC0124002B) across the U.S. due to incorrect capsule imprints. This event highlights critical labeling compliance risks for procurement and regulatory teams, necessitating immediate review of supplier quality agreements and internal quality control processes to mitigate supply chain disruptions and ensure product integrity.

REGULATORY INTELLIGENCE
2025-01-22

Viatris Inc. Recalls Cardura XL (Doxazosin) Due to Impurity Failures: Supply Chain and Regulatory Implications

Viatris Inc. has completed a Class II recall (D-0204-2025) of 6,605 bottles of Cardura XL (doxazosin mesylate) extended-release tablets 4 mg due to out-of-specification results for impurity compound B. This event underscores Viatris's recurring quality control challenges, necessitating immediate supply chain risk assessment and diversification strategies for procurement and regulatory leaders to ensure product availability and compliance.

REGULATORY INTELLIGENCE
2025-01-15

Eugia US LLC Initiates Nationwide Recall of Progesterone Injection Dueings to Particulate Matter

Eugia US LLC has initiated a Class II nationwide recall of 17,300 vials of Progesterone Injection USP due to particulate matter, specifically a glass piece. This event highlights critical quality control vulnerabilities in the sterile injectable supply chain, particularly for products manufactured internationally. Procurement and regulatory teams must assess immediate supply risks and reinforce supplier qualification protocols for Progesterone.

REGULATORY INTELLIGENCE
2025-01-15

FDA Class II Recall: Jubilant Radiopharma's Technetium Tc 99m Sulfur Colloid Injection Fails Stability

Jubilant Draximage Inc., dba Jubilant Radiopharma, has initiated a Class II recall for 5,209 kits of Technetium Tc 99m Sulfur Colloid Injection due to failed stability specifications. This US nationwide recall, originating from their Kirkland, Canada facility, poses immediate supply chain disruption for diagnostic imaging centers, necessitating urgent procurement re-evaluation and robust quality assurance from all radiopharmaceutical suppliers.

REGULATORY INTELLIGENCE
2025-01-15

American Health Packaging Initiates Nationwide Clobazam Recall Over Foreign Tablet Contamination

American Health Packaging has initiated a nationwide Class II recall of 5,178 cartons of Clobazam Tablets, 10 mg, due to the critical presence of foreign tablets or capsules. This voluntary action, impacting Lot #1019594, underscores significant quality control failures. Procurement and regulatory teams must immediately assess inventory, patient safety risks, and review supplier qualification protocols to mitigate supply chain vulnerabilities for this essential antiepileptic.

REGULATORY INTELLIGENCE
2025-01-15

West-Ward Columbus Inc Initiates Class III Recall of Methadone Hydrochloride Tablets Over Illegible Unit-Dose Labeling

West-Ward Columbus Inc has initiated a Class III recall of 2,591 boxes of Methadone Hydrochloride Tablets, 5mg, due to illegible unit-dose identification. This event, distributed by Hikma Pharmaceuticals USA Inc., signals potential dispensing errors and adds to West-Ward's history of quality control issues, demanding immediate attention from procurement and regulatory teams to assess supply chain risks and ensure patient safety.

REGULATORY INTELLIGENCE
2025-01-15

Endo USA, Inc. Faces FDA Class I Recall for Clonazepam ODT Due to Critical Labeling Error

Endo USA, Inc. has initiated a voluntary Class I recall for 8,029 cartons of Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg. This critical action stems from a labeling error where cartons displayed incorrect strength, posing significant patient safety risks. Procurement and regulatory teams must assess immediate supply chain disruptions and scrutinize quality control protocols for similar products.

REGULATORY INTELLIGENCE
2025-01-15

FDC Limited Faces Fourth Ophthalmic Solution Recall: Ciprofloxacin Impacted by Recurring Container Defects

FDC Limited has initiated a Class II recall (D-0182-2025) for 136,181 bottles of Ciprofloxacin Ophthalmic Solution USP, 0.3%, due to a defective container issue. This marks the fourth such recall for FDC Limited's ophthalmic products in under a year, signaling persistent quality control challenges at its Aurangabad, India facility. Procurement and regulatory teams must reassess supply chain exposure and diversify sourcing to mitigate ongoing risks.

REGULATORY INTELLIGENCE
2025-01-15

FDA Class II Recall: Metformin HCl ER Contamination by Granules India for Quallent Pharmaceuticals Signals Supply Chain Risk

Quallent Pharmaceuticals Health LLC faces a Class II FDA recall (D-0192-2025) for Metformin HCl ER 500 mg tablets, manufactured by Granules India Limited, due to Paracetamol contamination. This event, now terminated, highlights critical quality control vulnerabilities in contract manufacturing. Procurement and regulatory teams must scrutinize supplier quality systems, especially for essential medications like Metformin, to mitigate supply chain risks and ensure patient safety.

REGULATORY INTELLIGENCE
2025-01-15

Rising Pharma Recalls Duloxetine 30 mg Due to CGMP Deviations and N-nitroso-duloxetine Impurity

Rising Pharma Holding, Inc. has initiated a Class II recall for 42,527 bottles of Duloxetine Delayed-Release Capsules USP 30 mg due to CGMP deviations and N-nitroso-duloxetine impurity exceeding interim limits. This event underscores critical supply chain vulnerabilities and regulatory compliance risks for procurement and regulatory affairs teams, demanding immediate assessment of existing inventories and supplier qualification processes to mitigate disruption and ensure patient safety.

REGULATORY INTELLIGENCE
2025-01-08

FDA Class II Recall: Lupin's Levothyroxine Sodium Tablets Fail Impurity Specifications, Impacting US Supply Chain

Lupin Pharmaceuticals Inc. initiated a Class II recall for Levothyroxine Sodium Tablets (ANDA209713) due to impurity failures from its Pithampur, India, manufacturing site. This event, impacting 480,000 tablets distributed in the US, necessitates immediate action for procurement and supply chain leaders to assess exposure and diversify sourcing to mitigate future disruption risks.

REGULATORY INTELLIGENCE
2025-01-08

AvKARE Initiates Nationwide Recall of Carboxymethylcellulose Sodium Ophthalmic Solution Due to Label Mix-Up

AvKARE has initiated a Class III recall (D-0175-2025) for 16,677 cartons of Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% due to a label mix-up. This voluntary action, stemming from their Pulaski, TN facility, highlights persistent quality control challenges at AvKARE, impacting supply chain reliability and demanding immediate risk assessment from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-01-08

Viona Pharmaceuticals Recalls Dapsone Gel 7.5% Nationwide Due to Crystallization: Supply Chain and Quality Implications

Viona Pharmaceuticals Inc. has initiated a US nationwide Class II voluntary recall of 2,760 packs of Dapsone Gel 7.5% (NDC 72578-094-03) due to crystallization. This action, impacting lots T400514 and T400808, necessitates immediate review of supply chain integrity and quality assurance protocols for topical formulations. Procurement and regulatory teams must assess exposure and potential sourcing alternatives to mitigate disruption.

REGULATORY INTELLIGENCE
2025-01-08

Somerset Therapeutics Initiates Class III Recall of Atropine Sulfate Ophthalmic Solution Due to Impurities

Somerset Therapeutics, LLC has voluntarily recalled 5,870 bottles of Atropine Sulfate Ophthalmic Solution, USP 1%, NDC 70069-716-01, nationwide in the United States. This Class III recall, initiated December 16, 2024, was due to the product failing impurities and degradation specifications. The recall, impacting lot A240211, terminated on June 10, 2025, underscoring critical quality control vigilance for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2025-01-01

Glenmark Pharmaceuticals Recalls Chlorpromazine HCl Tablets Over Nitrosamine Impurity: Critical Supply Chain Implications

Glenmark Pharmaceuticals Inc., USA has initiated a Class II recall (D-0159-2025) for Chlorpromazine Hydrochloride Tablets due to N-Nitroso-Desmethyl Chlorpromazine impurity exceeding FDA limits. This CGMP deviation highlights critical quality control challenges, impacting supply chain stability and regulatory compliance for procurement directors. Companies must reassess supplier qualification and impurity testing protocols for active pharmaceutical ingredients, especially those manufactured offshore.

REGULATORY INTELLIGENCE
2025-01-01

Curium US LLC Initiates Class II Recall of Technetium Tc 99m Sestamibi Due to Sterility Concerns

Curium US LLC has initiated a Class II recall (D-0164-2025) for 5,160 vials of Technetium Tc 99m Sestamibi Injection Kits, distributed nationwide across the USA and Canada. The recall stems from a critical lack of sterility assurance and improper vial crimps, directly impacting product integrity. This event necessitates immediate action from procurement and supply chain leaders to mitigate disruption and ensure patient safety.

REGULATORY INTELLIGENCE
2025-01-01

RemedyRepack Inc. Initiates Class II Recall of Duloxetine Capsules Due to Nitrosamine Impurity and CGMP Deviations

RemedyRepack Inc. has initiated a nationwide Class II recall for Duloxetine Delayed-Release Capsules, 60 mg, due to N-nitroso-duloxetine impurity exceeding interim limits and Current Good Manufacturing Practice (CGMP) deviations. This event, following prior recalls, signals escalating compliance risks for procurement and regulatory affairs teams sourcing from RemedyRepack Inc.

REGULATORY INTELLIGENCE
2025-01-01

FDA Class II Recall: PD-Rx Pharmaceuticals' Duloxetine Contaminated with N-Nitroso-Duloxetine

PD-Rx Pharmaceuticals, Inc. initiated a Class II recall for 70 bottles of Duloxetine DR USP 30 mg due to N-Nitroso-Duloxetine, an NDSRI, exceeding acceptable limits. This CGMP deviation highlights critical quality control failures. Procurement and regulatory teams must scrutinize current supply chains for similar nitrosamine risks and verify supplier compliance to safeguard product integrity and patient safety.

REGULATORY INTELLIGENCE
2025-01-01

Breckenridge Pharmaceutical Recalls Duloxetine Due to N-Nitroso Impurity: Major CGMP Deviations at Manufacturer Towa Pharmaceutical Europe Trigger Nationwide US Action

Breckenridge Pharmaceutical, Inc. has initiated a Class II recall of 163,883 bottles of Duloxetine Delayed-Release Capsules, 30mg, across the US. This action stems from significant CGMP deviations at manufacturer Towa Pharmaceutical Europe, S.L., specifically the presence of N-nitroso-duloxetine impurity above FDA interim limits. This event signals heightened regulatory scrutiny on nitrosamine control and supply chain integrity for pharmaceutical decision-makers.

REGULATORY INTELLIGENCE
2025-01-01

FDA Class II Recall: Aurobindo Pharma's Duloxetine Capsules Impact U.S. Supply Chain Due to N-nitroso-duloxetine Impurity

Amerisource Health Services LLC has initiated a nationwide Class II recall of Aurobindo Pharma Limited's Duloxetine Delayed-Release Capsules, 30 mg. This action stems from Current Good Manufacturing Practice (CGMP) deviations, specifically the presence of N-nitroso-duloxetine impurity exceeding interim limits. This event signals critical supply chain and regulatory risks for procurement and regulatory affairs teams.

REGULATORY INTELLIGENCE
2024-12-25

Keystone Industries' Benzocaine Gel Recall: CGMP Violations Impact Global Dental Supply Chains

Keystone Industries initiated a Class II recall (D-0145-2025) for SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL due to critical CGMP deviations. The Quality Unit rejected bulk product from a scratched mixing vessel, yet it was inadvertently released and distributed across the USA, Canada, and Latin America. This event highlights significant supply chain integrity risks for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-12-25

Provepharm Inc. Initiates Class II Recall of Dihydroergotamine Mesylate Injection Due to Discoloration, Impacting US Supply

Provepharm Inc. has initiated a voluntary Class II recall for 10,800 ampules of Dihydroergotamine Mesylate Injection distributed nationwide in the United States. This action, prompted by discoloration, highlights critical quality control vulnerabilities in pharmaceutical manufacturing. Procurement and regulatory teams must assess supply chain resilience and review internal quality assurance protocols to mitigate similar risks.

REGULATORY INTELLIGENCE
2024-12-25

Keystone Industries Initiates Class II Recall for Gelato Benzocaine Gel Due to CGMP Deviations

Keystone Industries has executed a Class II recall (D-0137-2025) for its Gelato Benzocaine 20% Topical Gel Anesthetic. This action stems from critical CGMP deviations where a quality-rejected batch was inadvertently released and shipped. This event underscores significant supply chain risks for distributors and healthcare providers across the USA, Canada, and Latin American markets.

REGULATORY INTELLIGENCE
2024-12-25

Aurobindo Pharma USA Inc. Initiates Nationwide Recall of Nebivolol Tablets Over Nitrosamine Impurity Exceeding FDA Limits

Aurobindo Pharma USA Inc. has initiated a Class II recall of Nebivolol Tablets (2.5 mg) across the USA due to N-Nitroso Nebivolol, a nitrosamine impurity, exceeding acceptable intake limits. This CGMP deviation poses significant regulatory and supply chain risks for procurement and regulatory affairs teams, necessitating immediate assessment of existing stock and sourcing strategies for hypertension treatments.

REGULATORY INTELLIGENCE
2024-12-25

FDA Class II Recall: Regenerative Processing Plant's REGENER-EYES Ophthalmic Solution Lacks Sterility Assurance

Regenerative Processing Plant, LLC has completed a Class II recall of 170,812 bottles of LITE Regener-Eyes Ophthalmic Solution due to a critical lack of sterility assurance. This event, initiated December 10, 2024, impacts nationwide U.S. distribution, necessitating immediate supply chain review for procurement directors. The termination on June 27, 2025, confirms the closure of this specific recall, yet highlights ongoing risks in ophthalmic product manufacturing.

REGULATORY INTELLIGENCE
2024-12-25

APOTHECUS PHARMACEUTICAL CORP. Faces Recurring CGMP Violations: VCF Contraceptive (NONOXYNOL-9) Recall Signals Heightened FDA Scrutiny

APOTHECUS PHARMACEUTICAL CORP. faces a Class II voluntary recall of 33,659 retail boxes of VCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9) due to critical CGMP deviations, specifically out-of-specification assay results. This marks a recurring compliance issue for the Hicksville, NY-based manufacturer, impacting supply chains in the USA and Hong Kong. Procurement and regulatory teams must assess immediate product availability risks and long-term supplier reliability, given the pattern of quality control failures.

REGULATORY INTELLIGENCE
2024-12-18

Mylan Institutional Inc. Initiates Class II Recall of Levothyroxine Sodium Due to Potency Issues, Impacting US Supply

Mylan Institutional Inc. has initiated a Class II recall (D-0133-2025) for 1,664 cartons of Levothyroxine Sodium Tablets, 125 mcg, distributed nationwide in the USA. The recall stems from critical subpotent and superpotent drug findings, posing significant risks for patients and demanding immediate attention from procurement and regulatory teams managing thyroid medication supply chains.

REGULATORY INTELLIGENCE
2024-12-18

Mylan Institutional Recalls Subpotent and Superpotent Levothyroxine Sodium, Raising Thyroid Medication Supply Concerns

Mylan Institutional Inc. has initiated a Class II recall for 205 cartons of Levothyroxine Sodium Tablets, USP, 175 mcg, due to subpotent and superpotent drug findings. This voluntary, nationwide recall, effective November 19, 2024, highlights critical quality control failures impacting a vital thyroid medication, necessitating immediate supply chain risk assessment for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-12-18

Viatris Initiates Class II Recall of Levothyroxine Sodium Tablets Due to Potency Failures, Raising Supply Chain Concerns

Viatris Inc. has initiated a Class II recall of 9,828 bottles of Levothyroxine Sodium Tablets USP, 150 mcg, due to critical potency failures. This voluntary, firm-initiated action highlights significant quality control issues for a vital generic drug, impacting supply stability across the U.S. and Puerto Rico and demanding immediate procurement and regulatory review.

REGULATORY INTELLIGENCE
2024-12-18

Biocompatibles UK's Varithena Recall Highlights Critical Packaging Quality Control for Injectable Foam

Biocompatibles UK, Ltd. initiated a Class III recall (D-0113-2025) for 432 units of its Varithena (polidocanol injectable foam) Administration Packs distributed nationwide in the USA. The issue involved incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes being packaged instead of Luer Solo syringes. This recall, initiated August 15, 2024, and terminated February 21, 2025, underscores the critical need for stringent quality control in medical device component packaging.

REGULATORY INTELLIGENCE
2024-12-18

LNK International's Kirkland Cold & Flu Recall Highlights Critical CGMP Deviations for Supply Chain Leaders

LNK International, Inc. initiated a Class II recall (D-0115-2025) for Kirkland Severe Cold & Flu Plus Congestion due to Current Good Manufacturing Practice (CGMP) deviations. Products released should have been rejected, impacting 8,640 boxes distributed nationwide via Costco Wholesale Corporation. This event underscores the critical need for robust supplier quality assurance in pharmaceutical procurement and supply chain management.

REGULATORY INTELLIGENCE
2024-12-18

Ascend Laboratories Recalls Dabigatran Etexilate Due to Nitrosamine Impurity: Supply Chain Alert

Ascend Laboratories, LLC has initiated a Class II recall of Dabigatran Etexilate 75 mg capsules due to N-nitroso-Dabigatran impurity exceeding interim limits. This voluntary recall, involving 1971 bottles manufactured by Alkem Laboratories Ltd. in India, signals critical supply chain vulnerabilities and heightened regulatory scrutiny on nitrosamine control, impacting procurement and regulatory strategies for anticoagulant medications.

REGULATORY INTELLIGENCE
2024-12-11

Glenmark Pharmaceuticals Recalls Diltiazem Hydrochloride Due to Nitrosamine Impurity, Raising Supply Chain Concerns

Glenmark Pharmaceuticals Inc., USA has initiated a Class II nationwide recall of 4,704 bottles of Diltiazem Hydrochloride Extended-Release Capsules due to cGMP deviations. The recall, D-0097-2025, stems from N-nitroso-Desmethyl-Diltiazem impurity levels exceeding FDA interim limits. This event underscores persistent nitrosamine risks and highlights critical cGMP compliance challenges for pharmaceutical manufacturers, impacting supply chain reliability and regulatory standing.

REGULATORY INTELLIGENCE
2024-12-11

Aurobindo Pharma's Cinacalcet Recall Over Nitrosamine Impurity Signals Heightened FDA cGMP Scrutiny

Aurobindo Pharma USA Inc. initiated a Class II recall of Cinacalcet Tablets due to N-nitroso Cinacalcet impurity exceeding FDA limits, stemming from cGMP deviations at its India manufacturing site. This event signals heightened regulatory scrutiny on nitrosamine control and demands immediate action from procurement and regulatory teams to assess supply chain risks and ensure compliance.

REGULATORY INTELLIGENCE
2024-12-11

Zydus Pharmaceuticals Initiates Nationwide Recall of Esomeprazole Magnesium Due to NDC Labeling Error

Zydus Pharmaceuticals (USA) Inc. has initiated a Class III nationwide recall of 4404 packs of Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg. The recall, D-0102-2025, stems from an incorrect NDC number on product labeling. This event signals a quality control lapse, requiring immediate action from procurement and regulatory teams to assess inventory and ensure compliance across the USA.

REGULATORY INTELLIGENCE
2024-12-11

Midlab Incorporated Faces FDA Class II Recall Over Microbial Contamination in Antibacterial Hand Soap

Midlab Incorporated initiated a Class II recall for ROYALAB Germ Away Antibacterial Hand Soap due to cGMP deviations and microbial contamination. This impacts procurement and regulatory teams reliant on the Chloroxylenol 0.1% product, necessitating immediate supply chain review and robust quality assurance protocols to mitigate disruption and ensure product safety.

REGULATORY INTELLIGENCE
2024-12-11

FDA Class II Recall: Amerisource Health Services Initiates Duloxetine Recall Over N-nitroso-duloxetine Impurity

Amerisource Health Services LLC has initiated a Class II recall of 8,561 bottles of Duloxetine Delayed-Release Capsules, 60 mg, due to N-nitroso-duloxetine impurity above interim limits. This voluntary action, stemming from CGMP deviations at manufacturer Aurobindo Pharma Limited, signals heightened regulatory scrutiny on nitrosamine contamination, impacting supply chains and demanding immediate risk assessment for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-12-11

Rising Pharma Recalls Duloxetine DR Capsules Nationwide Over N-nitroso-duloxetine Impurity and CGMP Deviations

Rising Pharma Holding, Inc. has initiated a Class II nationwide recall of 233,003 bottles of Duloxetine DR Capsules USP 60 mg due to N-nitroso-duloxetine impurity exceeding interim limits. This CGMP deviation highlights critical quality control failures, posing significant supply chain and regulatory compliance risks for procurement and regulatory affairs teams sourcing similar active pharmaceutical ingredients.

REGULATORY INTELLIGENCE
2024-12-11

American Regent Initiates Class II Recall of Venofer (Iron Sucrose) Injection Over Glass Delamination Risk

American Regent, Inc. has initiated a Class II recall for Venofer (iron sucrose) Injection due to potential glass delamination, leading to particulate matter. This event, D-0080-2025, impacts nationwide supply in the USA, demanding immediate attention from procurement, regulatory, and supply chain leaders to assess inventory, patient safety, and future supply resilience for critical parenteral iron therapies.

REGULATORY INTELLIGENCE
2024-12-11

Lannett Company's Lisdexamfetamine Dimesylate Recalled by FDA Over Content Uniformity Failure

Lannett Company, Inc. initiated a nationwide Class II recall for 1,608 bottles of Lisdexamfetamine Dimesylate Capsules (10 mg) due to failed content uniformity specifications. This FDA-terminated recall highlights critical quality control issues for procurement directors and regulatory affairs heads, necessitating immediate supply chain review and enhanced supplier due diligence for Lannett's products.

REGULATORY INTELLIGENCE
2024-12-11

FDA Class I Recall: Boulla LLC's VitalityXtra Capsules Contain Undeclared Sildenafil and Diclofenac, Lacking NDA/ANDA Approval

Boulla LLC faces a Class I FDA recall (D-0083-2025) for its VitalityXtra Capsules, 500 mg, distributed by VitalityXtra. The product, marketed without an approved NDA/ANDA, contains undeclared sildenafil and diclofenac. This presents significant regulatory and safety risks, demanding immediate action from procurement and regulatory affairs teams to assess supply chain exposure and ensure product integrity.

REGULATORY INTELLIGENCE
2024-12-11

AvKARE Initiates Class II Recall of Cinacalcet Tablets Over Nitrosamine Impurity Concerns

AvKARE has initiated a nationwide Class II recall for 2,396 bottles of Cinacalcet Tablets, 60 mg, due to unacceptable levels of N-Nitroso-Cinacalcet, a nitrosamine impurity. This event highlights critical CGMP deviations and mandates immediate action for procurement and supply chain leaders to assess risk and secure alternative sourcing strategies for this essential drug.

REGULATORY INTELLIGENCE
2024-12-04

Neogen Corporation Faces FDA Class II Recall for LICEOUT Amidst CGMP Violations: Supply Chain and Regulatory Implications

Neogen Corporation has initiated a Class II recall of 5,328 sachets of LICEOUT, a liquid lice treatment, due to critical CGMP violations at its Lexington, KY facility. This event necessitates immediate action for procurement directors and supply chain VPs to assess continuity, especially for institutional distributors like Bob Barker Company, and highlights the imperative for robust supplier quality assurance.

REGULATORY INTELLIGENCE
2024-12-04

Walmart's Equate Lidocaine Patches Recalled Over cGMP Deviations by Unexo Life Sciences

Walmart Inc. faces significant supply chain and brand implications following a Class II recall of 1,101,600 EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCHES. Initiated by Unexo Life Sciences Private Limited due to cGMP Deviations, this nationwide US recall highlights critical manufacturing quality control failures. Procurement and regulatory teams must scrutinize contract manufacturing oversight, assess current supplier compliance, and diversify sourcing strategies for topical anesthetics to mitigate future disruption and uphold product integrity.

REGULATORY INTELLIGENCE
2024-12-04

Unexo Life Sciences Faces FDA Class II Recall for 6.8 Million ABSORBINE jr. Menthol Patches Over cGMP Deviations

Unexo Life Sciences Private Limited initiated a Class II recall of 6,848,820 ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, due to cGMP deviations. This event, now terminated, highlights critical quality control risks for procurement and supply chain leaders sourcing from India, demanding rigorous due diligence to mitigate disruption and ensure product integrity in the US market.

REGULATORY INTELLIGENCE
2024-11-27

Dr. Reddy's Laboratories Initiates Class III Recall of IBU (Ibuprofen) 600 mg Tablets Due to Failed Specifications

Dr. Reddy's Laboratories, Inc. has initiated a voluntary Class III recall of IBU (ibuprofen) 600 mg tablets nationwide in the USA. This action, identified as D-0047-2025, stems from the product failing tablet/capsule specifications. Procurement and regulatory teams must assess supply chain stability and quality control protocols, particularly for generic NSAIDs, to mitigate potential disruptions and ensure product integrity.

REGULATORY INTELLIGENCE
2024-11-27

The Harvard Drug Group LLC Initiates Class II Recall of Guaifenesin Dextromethorphan Syrup Due to Failed Impurity Specifications

The Harvard Drug Group LLC has initiated a Class II recall for its Guaifenesin Dextromethorphan Syrup nationwide. This action, due to failed impurity/degradation specifications, impacts three specific lots. Procurement, regulatory, and supply chain leaders must assess their inventory and distribution networks for this widely used OTC product, ensuring compliance and mitigating potential supply disruptions and reputational damage.

REGULATORY INTELLIGENCE
2024-11-27

FDA Scrutiny: Lupin Pharmaceuticals Recalls Ramipril Over Unapproved API Sourcing, Signaling Broader CGMP Risks

Lupin Pharmaceuticals Inc. has initiated a Class II recall (D-0054-2025) of 357,414 bottles of Ramipril Capsules USP 10 mg due to sourcing active pharmaceutical ingredient from an unapproved vendor, a critical CGMP deviation. This event underscores the imperative for robust supplier qualification and continuous oversight in the global supply chain, directly impacting procurement strategies and regulatory compliance for generic drug manufacturers.

REGULATORY INTELLIGENCE
2024-11-27

Padagis US LLC Initiates Class III Recall of Triamcinolone Acetonide Cream Due to Potency Deviations

Padagis US LLC has completed a Class III recall (D-0048-2025) of 10,872 jars of Triamcinolone Acetonide Cream USP, 0.025%, due to subpotent and superpotent drug findings. This voluntary action, initiated October 11, 2024, stemmed from out-of-specification stability test results at their Minneapolis, MN facility. Procurement and regulatory teams must scrutinize supplier quality systems, particularly for long-term stability and container uniformity, to mitigate supply chain risks.

REGULATORY INTELLIGENCE
2024-11-27

Noven Pharmaceuticals Initiates Nationwide Recall of Xelstrym Dextroamphetamine Transdermal Systems Over Adhesive Defect

Noven Pharmaceuticals Inc initiated a nationwide Class II recall of 685 boxes of Xelstrym (dextroamphetamine) transdermal systems due to a defective adhesive delivery system failing Coldflow specifications. This event impacts patient access to a critical CNS stimulant and necessitates immediate supply chain risk assessment for distributors and healthcare providers. Procurement teams must evaluate alternative sourcing strategies to mitigate potential supply disruptions for this essential medication.

REGULATORY INTELLIGENCE
2024-11-27

Safecor Health's Aspirin 81 mg Recall: cGMP Deviations Expose Packaging Integrity Risks

Safecor Health, LLC has initiated a Class II nationwide recall of its Aspirin Chewable tablet 81 mg due to cGMP deviations involving separating blister card-foils. This event, impacting 1470 boxes, underscores critical packaging integrity risks for procurement and regulatory teams. Decision-makers must assess supply chain exposure, review quality assurance protocols for OTC products, and consider the broader implications for patient safety and market stability.

REGULATORY INTELLIGENCE
2024-11-20

Cipla USA Initiates Nationwide Class II Recall of Lanthanum Carbonate Chewable Tablets Due to Quality Failures

Cipla USA, Inc. has initiated a Class II recall (D-0043-2025) for 1,875 boxes of Lanthanum Carbonate Chewable Tablets, 1000mg, distributed nationwide. The recall, stemming from complaints of crushed and broken tablets, highlights critical quality control vulnerabilities. This event demands immediate attention from procurement and supply chain leaders to assess inventory risks and ensure patient safety.

REGULATORY INTELLIGENCE
2024-11-20

The Harvard Drug Group Recalls Hydralazine HCl Tablets Due to Impurity Failures

The Harvard Drug Group LLC initiated a Class III recall of 25,814 Hydralazine HCl Tablets, USP, 25mg, distributed nationwide. The recall, now terminated, stemmed from failed impurity/degradation specifications during routine stability testing. This event underscores the critical need for robust quality control and supplier vigilance for pharmaceutical procurement and regulatory affairs teams.

REGULATORY INTELLIGENCE
2024-11-13

Direct Rx Initiates Class II Recall of Ibuprofen 800mg Due to Impurity Failures

Direct Rx has initiated a Class II recall for 1,410 bottles of Ibuprofen 800mg across the US, citing impurity specification failures during 18-month stability testing. This event, impacting multiple NDC codes and lots manufactured by Dr. Reddy's Laboratories LA, LLC, necessitates immediate supply chain review. Procurement and regulatory teams must assess current stock, potential market shortages for Ibuprofen, and evaluate supplier qualification processes to mitigate future risks from degradation issues.

REGULATORY INTELLIGENCE
2024-11-13

Dr. Reddy's Laboratories Initiates Class II Recall of Morphine Sulfate ER Tablets Due to Impurity Failure

Dr. Reddy's Laboratories, Inc. has initiated a Class II recall for Morphine Sulfate Extended-Release Tablets 15 mg (Lot# FG14062) due to failed impurity specifications. This voluntary, firm-initiated recall impacts 2,040 bottles distributed nationwide in the USA. Procurement and regulatory teams must assess supply chain exposure and verify product quality to mitigate potential disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2024-11-13

Viona Pharmaceuticals Initiates Class II Recall of Dapsone Gel 7.5% Due to Crystallization

Viona Pharmaceuticals Inc. has initiated a voluntary Class II recall for 6048 pumps of Dapsone Gel 7.5% nationwide, citing crystallization. This event, impacting lots T401151 and T400806 manufactured by Zydus Lifesciences, necessitates immediate supply chain review for procurement directors and regulatory heads to mitigate disruption and assess quality control vulnerabilities.

REGULATORY INTELLIGENCE
2024-11-13

FDC Limited's Recurring Timolol Maleate Recall Signals Persistent Container Defects, Heightening US Supply Chain Risk

FDC Limited has initiated a Class II recall of 155,232 bottles of Timolol Maleate Ophthalmic Solution USP, 0.5%, due to defective containers. This marks the third such recall for the Aurangabad, India-based manufacturer in 2024, distributed by Rising Pharma Holdings, Inc. This recurring issue underscores significant quality control deficiencies, posing substantial supply chain and regulatory risks for procurement and regulatory affairs teams.

REGULATORY INTELLIGENCE
2024-11-06

Accord Healthcare Recalls Cinacalcet Tablets Over Nitrosamine Impurity Exceeding FDA Limits

Accord Healthcare, Inc. initiated a Class II recall of Cinacalcet Tablets, 90 mg, due to N-nitroso-cinacalcet impurity above acceptable daily intake limits. Manufactured by Intas Pharmaceuticals Limited, India, this event underscores critical supply chain and regulatory risks. Procurement directors must assess inventory and diversify sourcing, while regulatory affairs must reinforce impurity control protocols to mitigate future compliance issues and ensure patient safety.

REGULATORY INTELLIGENCE
2024-11-06

FDA Class II Recall: Dr. Reddy's Cinacalcet Tablets Hit by N-nitroso Impurity, Triggering Supply Chain Review

Dr. Reddy's Laboratories, Inc. has initiated a Class II recall of Cinacalcet Tablets, 90 mg, due to N-nitroso Cinacalcet impurity exceeding FDA limits. This voluntary, nationwide recall of 10,584 bottles impacts procurement and regulatory teams, necessitating immediate supply chain review and risk mitigation strategies for this critical generic medication.

REGULATORY INTELLIGENCE
2024-11-06

BLI International Chlorpheniramine Maleate Recall: Superpotency Triggers FDA Class II Action

BLI International initiated a Class II recall for 4,901 cases of Chlorpheniramine Maleate 4 mg tablets due to superpotency from stability failure. This terminated recall, impacting private label customers in OH and MO, underscores critical quality control challenges. Procurement and regulatory teams must scrutinize supplier stability data to mitigate supply chain and patient safety risks.

REGULATORY INTELLIGENCE
2024-10-30

Fresenius Kabi Compounding Recalls NORepinephrine Bitartrate Due to cGMP Violations, Signaling Heightened FDA Scrutiny

Fresenius Kabi Compounding, LLC faces a Class II recall of NORepinephrine Bitartrate Injection due to cGMP violations at its Canton, MA site. This event, impacting 125 nationwide accounts, highlights critical supply chain vulnerabilities for essential medications. Procurement and regulatory teams must assess exposure, identify alternative suppliers, and reinforce compliance protocols to mitigate disruption and address the FDA's heightened scrutiny on manufacturing quality across the pharmaceutical sector.

REGULATORY INTELLIGENCE
2024-10-30

FDA Mandates Class II Recall for C & A Naturistics' AK Forte Due to Undeclared Diclofenac and Acetaminophen

C & A Naturistics initiated a Class II recall for AK Forte Ortiga y Omega 3 due to undeclared diclofenac and acetaminophen, marketed without FDA approval. This event highlights critical supply chain and regulatory compliance failures. Procurement and regulatory teams must scrutinize suppliers, especially for products lacking proper authorization, to mitigate significant business and patient safety risks.

REGULATORY INTELLIGENCE
2024-10-30

FDA Initiates Class II Recall for Akron Pharma's OneLAX Docusate Sodium Liquid Due to CGMP Deviations

Akron Pharma, Inc. has initiated a nationwide Class II recall (D-0025-2025) for 10,845 bottles of OneLAX Docusate Sodium Liquid due to Current Good Manufacturing Practice (CGMP) deviations. This event necessitates immediate review by procurement, supply chain, and regulatory teams to assess inventory, mitigate disruption, and ensure compliance with FDA standards for this critical over-the-counter laxative.

REGULATORY INTELLIGENCE
2024-10-23

Viona Pharmaceuticals Recalls Dapsone Gel 7.5% Due to Crystallization: Supply Chain and Regulatory Impact

Viona Pharmaceuticals Inc. has initiated a Class II recall of 2,544 pumps of Dapsone Gel 7.5% (ANDA214019) due to crystallization, impacting US distribution. This voluntary action, involving product manufactured by Zydus Lifesciences Ltd., highlights critical quality control and supply chain vulnerabilities for procurement and regulatory teams in the dermatological sector.

REGULATORY INTELLIGENCE
2024-10-23

Zhejiang Jingwei Pharmaceutical Initiates Class II Recall for Povidone-Iodine Due to Undeclared Excipients, Impacting US Supply

Zhejiang Jingwei Pharmaceutical Co., Ltd. has initiated a Class II recall for 295,164 tubes of Povidone-Iodine USP 10% antiseptic due to undeclared excipients. This event highlights critical supply chain and regulatory risks for procurement directors and regulatory affairs heads, underscoring the imperative for rigorous ingredient verification and robust supplier qualification, particularly for products sourced from China.

REGULATORY INTELLIGENCE
2024-10-23

FDA Class I Recall: Bionpharma's Atovaquone Oral Suspension Contaminated with Cohnella Bacteria

Bionpharma Inc. initiated a Class I recall for Atovaquone Oral Suspension due to Cohnella bacteria contamination, impacting 1,980 bottles nationwide. This event underscores critical risks in non-sterile product quality control and demands immediate attention from procurement and regulatory teams to assess supply chain vulnerabilities and ensure robust supplier qualification processes for essential medicines like Atovaquone.

REGULATORY INTELLIGENCE
2024-10-09

Gilead Sciences Initiates Class I Recall of 105,000 Veklury (Remdesivir) Vials Due to Glass Particulates

Gilead Sciences, Inc. has initiated a Class I recall of 105,000 vials of Veklury (remdesivir) for injection due to glass particulate matter. This voluntary, nationwide U.S. recall, terminated on July 29, 2025, signals significant supply chain disruption and heightened regulatory scrutiny on sterile injectable products, demanding immediate action from procurement and quality assurance teams.

REGULATORY INTELLIGENCE
2024-10-09

FDA Class I Recall: Supercore Products Group's Gold Hard Steel Plus Liquid Tainted with Undeclared APIs, Unapproved Marketing

Supercore Products Group Inc. faces a Class I FDA recall for Gold Hard Steel Plus Liquid, distributed nationwide and internationally. The product contains undeclared acetaminophen and sildenafil, marketed without an approved NDA/ANDA. This poses significant health risks and demands immediate action from global procurement and regulatory teams to reassess supplier vetting processes.

REGULATORY INTELLIGENCE
2024-10-09

Nivagen Pharmaceuticals Initiates Class II Recall of Atorvastatin Calcium Due to Foreign Tablet Contamination

Nivagen Pharmaceuticals has initiated a Class II recall for 2,328 bottles of Atorvastatin Calcium 40mg due to contamination with Carbamazepine. This event, originating from Umedica Laboratories in India, highlights critical cGMP failures in quality control and poses immediate supply chain and regulatory risks for procurement and regulatory affairs teams managing generic cardiovascular medications.

REGULATORY INTELLIGENCE
2024-10-02

Ascend Laboratories' Mycophenolic Acid Recall: Critical Dissolution Failure Impacts Immunosuppressant Supply

Ascend Laboratories, LLC has initiated a nationwide Class II recall for 117,493 bottles of Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, due to failed dissolution specifications. This event, impacting a critical immunosuppressant manufactured by Alkem Laboratories, LTD, India, underscores significant quality control vulnerabilities within the global pharmaceutical supply chain. Procurement and regulatory teams must immediately assess inventory, evaluate alternative suppliers, and reinforce supplier qualification protocols to mitigate patient access risks and ensure compliance.

REGULATORY INTELLIGENCE
2024-10-02

FDA Initiates Class II Recall for EnviroServe Chemicals' EnviroClean Hand Sanitizer Due to CGMP Deviations

EnviroServe Chemicals Inc. has initiated a Class II recall of 120 bottles of EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v) due to Current Good Manufacturing Practice (CGMP) deviations. This action, initiated September 18, 2024, by the FDA, impacts a single North Carolina distributor. Procurement and regulatory teams must assess supplier quality systems rigorously, especially for essential over-the-counter products like hand sanitizers.

REGULATORY INTELLIGENCE
2024-09-25

FDA Class III Recall: Rubicon Research's Acetazolamide Tablets Face Discoloration Issue, Impacting US Supply

Rubicon Research Private Limited faces an FDA Class III recall for 3,984 bottles of Acetazolamide Tablets, 125 mg, distributed nationwide in the US by Advagen Pharma Ltd, due to discoloration. This event signals potential quality control vulnerabilities at Rubicon's Ambarnath, India facility, necessitating immediate supply chain risk assessments and enhanced due diligence for procurement and regulatory teams sourcing from the region.

REGULATORY INTELLIGENCE
2024-09-18

PREQUEL SKIN Recalls 30,946 Tubes of Barrier Therapy Cream Due to Microbial Contamination

PREQUEL SKIN has initiated a voluntary Class II recall of 30,946 tubes of BARRIER THERAPY SKIN PROTECTANT CREAM due to microbial contamination. This event, impacting nationwide distribution, underscores critical quality control challenges in non-sterile drug products. Decision-makers must assess supply chain vulnerabilities and reinforce sterility assurance protocols to mitigate similar regulatory and reputational risks.

REGULATORY INTELLIGENCE
2024-09-18

FDA Class III Recall: Elevate Oral Care's Sodium Fluoride Product Pulled Due to Label Mix-Up

Elevate Oral Care has completed a Class III recall (D-0658-2024) of its Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor product. Initiated on August 20, 2024, the voluntary recall addressed a critical label mix-up affecting 120 direct customers nationwide. This event underscores the persistent risk of packaging errors in pharmaceutical supply chains, demanding robust quality control protocols from manufacturers and vigilant oversight from procurement teams.

REGULATORY INTELLIGENCE
2024-09-11

FDA Mandates Nationwide Recall of ProRx LLC's Compounded Tirzepatide Due to Sterility Concerns

ProRx LLC has initiated a nationwide Class II recall of 37 vials of compounded Tirzepatide injection from its Exton, PA facility, citing a lack of assurance of sterility. This event underscores critical quality control vulnerabilities in sterile compounding, necessitating immediate review of supplier qualification processes and robust quality assurance protocols for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-09-04

FDA Class II Recall: Dr. Reddy's Ibuprofen 400 mg Tablets Flagged for Impurity Exceeding Specifications

Dr. Reddy's Laboratories, Inc. is executing a Class II recall for 14,940 bottles of IBU Ibuprofen Tablets, 400 mg, distributed nationwide due to an unknown impurity exceeding specification limits. This event underscores critical quality control vulnerabilities in generic drug manufacturing. Procurement and supply chain leaders must reassess supplier qualification and diversify sourcing strategies to mitigate disruption risks and ensure patient safety.

REGULATORY INTELLIGENCE
2024-09-04

Dr. Reddy's Laboratories Initiates Class II Recall of Ibuprofen 800 mg Due to Impurity Exceedances

Dr. Reddy's Laboratories, Inc. has initiated a Class II recall of 103,298 bottles of IBU Ibuprofen Tablets, USP, 800 mg, distributed nationwide. This voluntary action, stemming from manufacturing in India, is due to unknown impurity levels exceeding FDA specifications. Procurement and regulatory teams must assess immediate supply chain disruptions and enhance due diligence for generic API sourcing to mitigate future risks.

REGULATORY INTELLIGENCE
2024-09-04

FDA Class II Recall: Preferred Pharmaceuticals Initiates Ibuprofen Recall Due to Impurity Specifications

Preferred Pharmaceuticals, Inc. has initiated a Class II recall for specific lots of Ibuprofen Tablets, USP 400mg, manufactured by Dr. Reddy's Laboratories. This recall, affecting 266 bottles distributed in CA and NV, stems from failed impurities/degradation specifications during 18-month stability testing. This event underscores critical supply chain and quality control diligence for pharmaceutical procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-09-04

FDA Class II Recall: Glenmark's Indomethacin Extended-Release Capsules Face Dissolution Failure, Raising Supply Chain Concerns

Glenmark Pharmaceuticals Inc., USA, initiated a nationwide Class II recall (D-0643-2024) for Indomethacin Extended-Release Capsules, 75 mg, due to failed dissolution specifications. This event, stemming from product manufactured by Glenmark Pharmaceuticals Limited in India, necessitates immediate action from procurement and regulatory teams to assess supply chain vulnerabilities and ensure product quality.

REGULATORY INTELLIGENCE
2024-09-04

Lupin Pharmaceuticals Initiates Nationwide Recall of Subpotent Cefixime Oral Suspension

Lupin Pharmaceuticals Inc. has executed a nationwide Class II recall for Cefixime for Oral Suspension due to subpotency identified during stability testing. This event, stemming from manufacturing at Lupin Limited in India, underscores critical quality control vulnerabilities in generic antibiotic supply chains. Procurement and regulatory teams must assess current sourcing strategies and supplier oversight for similar products.

REGULATORY INTELLIGENCE
2024-08-28

FDA Class II Recall: Teva Pharmaceuticals' Superpotent Testosterone Gel Raises Supply Chain Concerns

Teva Pharmaceuticals USA, Inc. has initiated a Class II recall for superpotent Testosterone Gel, 1.62%, impacting 7,080 unit-dose packets nationwide. This event, coupled with Teva's recent Warfarin Sodium recall, signals heightened regulatory scrutiny and demands immediate supply chain risk assessment for androgen therapies by procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-08-28

Hikma Pharmaceuticals Faces Class I Recall for Acetaminophen Injection Due to Critical Label Mix-up

Hikma Pharmaceuticals USA Inc. has initiated a Class I recall for 31,400 bags of Acetaminophen Injection due to a critical label mix-up, where Dexmedetomidine HCl was found in Acetaminophen overwraps. This high-severity event demands immediate action from procurement and regulatory teams to mitigate patient safety risks and ensure supply chain integrity for this essential intravenous medication.

REGULATORY INTELLIGENCE
2024-08-28

Zeco LLC Recalls Rubbing Alcohol (70% Isopropyl Alcohol) Over Non-Sterile Water CGMP Deviations

Zeco LLC has initiated a Class II recall for Rubbing Alcohol (70% Isopropyl Alcohol) and First-Aid Antiseptic due to critical CGMP deviations, specifically using non-sterile water in production. This impacts supply chains nationwide in the US and Canada. Procurement directors must reassess supplier qualification for antiseptic products, while regulatory affairs must ensure robust quality agreements to mitigate similar compliance risks.

REGULATORY INTELLIGENCE
2024-08-28

FDC Limited's Timolol Maleate Ophthalmic Solution Recalled: Recurring Container Defects Impact US Supply

FDC Limited has initiated a Class II recall for 176,784 bottles of Timolol Maleate Ophthalmic Solution USP, 0.5%, distributed nationwide in the U.S. The recall, D-0642-2024, stems from defective containers preventing solution dispensing. This marks a recurring issue for FDC's Aurangabad facility, previously identified for similar container defects with the same product. Procurement and regulatory teams must assess supply continuity and FDC's quality control.

REGULATORY INTELLIGENCE
2024-08-21

FDC Limited Faces Class II Recall for Defective Timolol Maleate Ophthalmic Solution in US Market

FDC Limited's voluntary Class II recall of 362,544 bottles of Timolol Maleate Ophthalmic Solution due to defective containers signals critical manufacturing control deficiencies. This event impacts US supply chains, particularly distributor Rising Pharma Holdings, Inc., and necessitates immediate procurement risk assessment for ophthalmic drug portfolios. Businesses must evaluate supplier quality systems to mitigate disruption and ensure patient safety.

REGULATORY INTELLIGENCE
2024-08-21

Taro Pharmaceuticals Initiates Class III Recall of Hydrocortisone Otic Solution Due to Impurity and Assay Failures

Taro Pharmaceuticals U.S.A., Inc. has initiated a Class III recall of Hydrocortisone 1% & Acetic Acid 2% Otic Solution, lot AD12890, due to out-of-specification impurities and low hydrocortisone assay. This voluntary action, affecting 96 vials distributed to a single entity, underscores critical quality control vulnerabilities for procurement and regulatory teams managing pharmaceutical supply chains.

REGULATORY INTELLIGENCE
2024-08-14

FDA Issues Class I Recall for A-S Medication Solutions' Mislabeled Acetaminophen Extra Strength Tablets

A-S Medication Solutions LLC initiated a Class I recall for 429 bottles of Acetaminophen Extra Strength 500 mg tablets due to a critical labeling error. Bottles were incorrectly marked with Aspirin 81 mg drug facts, posing significant health risks. This event underscores the imperative for robust quality control in pharmaceutical packaging operations, impacting procurement and regulatory strategies across the industry.

REGULATORY INTELLIGENCE
2024-08-14

Granules Consumer Health Inc. Faces Class III FDA Recall for Acetaminophen Labeling Error

Granules Consumer Health Inc. initiated a Class III voluntary recall of 21,192 bottles of Acetaminophen USP 500mg Rapid Release Gelcaps due to a labeling error. This incident, involving product manufactured in India and distributed via Walgreen Co., highlights critical vulnerabilities in pharmaceutical labeling quality control. Procurement and regulatory teams must scrutinize supplier quality agreements to mitigate similar supply chain disruptions.

REGULATORY INTELLIGENCE
2024-08-14

Novel Laboratories Recall: Defective Packaging Triggers Nationwide PEG-3350 Oral Solution Withdrawal

Novel Laboratories, Inc. d.b.a Lupin Somerset initiated a Class III recall for 13,200 cartons of PEG-3350 oral solution due to defective, non-sealed pouches. This voluntary nationwide recall, distributed by Teva Pharmaceuticals USA, Inc., highlights critical packaging integrity challenges. Procurement and supply chain leaders must scrutinize supplier quality controls to mitigate product leakage risks and ensure patient safety and supply continuity. The recall was terminated by the FDA on April 28, 2025.

REGULATORY INTELLIGENCE
2024-08-07

FDA Initiates Class II Recall of Eugia US LLC's Progesterone Injection Due to Glass Particulate Contamination

Eugia US LLC faces a Class II FDA recall for 17,136 vials of Progesterone Injection, USP, due to glass particulate contamination. This voluntary action, recall number D-0624-2024, impacts nationwide US distribution. Procurement and regulatory teams must assess immediate supply disruptions for this critical hormone therapy and review quality assurance protocols for sterile injectables, particularly those sourced internationally.

REGULATORY INTELLIGENCE
2024-08-07

Class I Recall: Amerisource Health Services Pulls Potassium Chloride Due to Dissolution Failure

Amerisource Health Services initiated a Class I recall of 61,231 bottles of Potassium Chloride Extended-Release Capsules due to failed dissolution specifications. Manufactured by Glenmark Pharmaceuticals, this nationwide US recall highlights critical quality control gaps impacting patient safety and supply chain stability. Procurement and regulatory teams must immediately assess inventory and re-evaluate supplier risk.

REGULATORY INTELLIGENCE
2024-08-07

FDA Class II Recall: Glenmark's Azelaic Acid Gel Faces CGMP Deviations, Impacting U.S. Supply

Glenmark Pharmaceuticals Inc., USA has initiated a Class II recall for 14,004 cartons of Azelaic Acid Gel, 15%, due to CGMP deviations at its Indian manufacturing facility. This voluntary action, impacting U.S. nationwide distribution, necessitates immediate supply chain risk assessment for procurement and regulatory teams, highlighting the critical need for robust supplier qualification and diversified sourcing strategies.

REGULATORY INTELLIGENCE
2024-07-31

GLOBAL WIDGET LLC Initiates Nationwide Recall of Subpotent Hemp Bombs CBD Pain Freeze

GLOBAL WIDGET LLC has initiated a nationwide Class III recall of 11,130 bottles of its Hemp Bombs CBD Pain Freeze due to subpotent menthol. This voluntary action, reference D-0615-2024, highlights critical quality control failures impacting product efficacy and regulatory compliance for the Tampa, FL-based distributor, necessitating immediate supply chain review for similar products.

REGULATORY INTELLIGENCE
2024-07-31

FDA Class II Recall: Zydus Venlafaxine Hydrochloride Extended-Release Fails Dissolution Specifications

Zydus Pharmaceuticals USA Inc. initiated a Class II recall (D-0617-2024) for Venlafaxine Hydrochloride Extended-Release Capsules due to failed dissolution specifications. This voluntary action, impacting nationwide distribution, underscores critical quality control challenges for the manufacturer, Zydus Lifesciences Ltd. The recall is now terminated, but highlights ongoing regulatory scrutiny for generic extended-release formulations.

REGULATORY INTELLIGENCE
2024-07-31

Washington Homeopathic Products Recalls Kits Over Ferrum Labeling Mix-Up: Implications for Supply Chain Vigilance

Washington Homeopathic Products, Inc. initiated a Class III recall (D-0618-2024) for its Complete 30C/200C Homeopathic Kit due to mislabeled Ferrum Phosphoricum 200C as Ferrum Metallicum 200C. This event, now terminated, underscores critical vulnerabilities in labeling integrity and quality control within the pharmaceutical supply chain, demanding heightened vigilance from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-07-24

StellaLife Oral Care Recall: Microbial Contamination Triggers Nationwide Action, Raising Compliance Concerns

StellaLife, Inc. faces regulatory scrutiny following a Class II recall of 31,110 units of its VEGA Oral Care Rinse due to *Terribacillus species* contamination. This voluntary, firm-initiated action, distributed nationwide to 60 physician offices, underscores critical quality control vulnerabilities in non-sterile product manufacturing. Decision-makers must assess supplier quality and recall readiness.

REGULATORY INTELLIGENCE
2024-07-24

Glenmark Pharmaceuticals Faces Class I Recall for Potassium Chloride Extended-Release Capsules Due to Dissolution Failure

Glenmark Pharmaceuticals Inc., USA has initiated a Class I recall for 36,630 bottles of Potassium Chloride Extended-Release Capsules, USP, due to failed dissolution specifications. This critical issue, originating from its Indian manufacturing facility, poses significant supply chain risks and demands immediate action from procurement and regulatory teams to ensure patient safety and maintain supply continuity for this essential electrolyte.

REGULATORY INTELLIGENCE
2024-07-24

FDA Class II Recall: RemedyRepack's Potassium Chloride Capsules Fail Dissolution Specifications

RemedyRepack Inc. has initiated a Class II recall for Potassium Chloride Micro 10mEq K Extended Release Capsules due to critical dissolution failures, indicating CGMP deviations. This nationwide recall, impacting 142 blister cards, highlights significant quality control lapses in repackaging operations, demanding immediate review of supplier qualification and quality assurance protocols by procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-07-24

FDA Terminates Sun Pharma's Nitrofurantoin Recall Amidst Recurring Dissolution Failures

SUN PHARMACEUTICAL INDUSTRIES INC faced an FDA Class II recall for Nitrofurantoin Capsules due to failed dissolution specifications. This event, now terminated, highlights recurring quality control challenges for the company, impacting supply chain stability for this essential antibiotic. Procurement and regulatory teams must assess current sourcing strategies and monitor Sun Pharma's broader compliance efforts.

REGULATORY INTELLIGENCE
2024-07-17

Suntegrity's Zinc Oxide Sunscreen Recall: CGMP Deviations Trigger Global Supply Chain Review

Synchronicity Spa, Inc. DBA Suntegrity has initiated a Class II recall (D-0589-2024) for 8,202 tubes of its IMPECCABLE SKIN sunscreen foundation, citing CGMP Deviations. This action impacts global distribution of the Zinc Oxide-based product, necessitating immediate supply chain assessments and regulatory compliance reviews for procurement and regulatory affairs teams across affected markets.

REGULATORY INTELLIGENCE
2024-07-17

Zydus Pharmaceuticals Initiates Class III Recall of Verapamil Hydrochloride Injection Due to Cross-Contamination Risk

Zydus Pharmaceuticals USA Inc. has initiated a Class III recall for 170,755 vials of Verapamil Hydrochloride Injection due to cross-contamination. This voluntary action, stemming from manufacturing in India, highlights critical quality control vulnerabilities. Procurement and supply chain leaders must assess current sourcing strategies and Zydus's remediation efforts to mitigate potential supply disruptions for this essential cardiovascular drug.

REGULATORY INTELLIGENCE
2024-07-17

FDA Initiates Class III Recall for Rising Pharma's Diflorasone Diacetate Ointment Due to Impurity Failures

Rising Pharma Holdings, Inc. has initiated a Class III recall (D-0599-2024) for 868 tubes of Diflorasone Diacetate Ointment, USP, 0.05%, due to failed impurity specifications at 12-month stability testing. This nationwide recall, impacting lot DI2303B, underscores critical quality control vulnerabilities for pharmaceutical procurement and regulatory affairs teams. Businesses must assess supply chain continuity and review quality assurance protocols for topical corticosteroid products.

REGULATORY INTELLIGENCE
2024-07-17

FDA Class II Recall: Baxter's Dianeal Peritoneal Dialysis Solution Faces Sterility Assurance Issues

Baxter Healthcare Corporation has initiated a Class II recall for 6,874 bags of Dianeal Low Calcium Peritoneal Dialysis Solution due to potential leaks in the connector assembly, compromising sterility. This event, impacting US and Canadian supply chains, necessitates immediate review of procurement strategies and quality assurance protocols for critical medical products, highlighting significant patient safety and commercial risks.

REGULATORY INTELLIGENCE
2024-07-10

Accord Healthcare Recalls Subpotent Dodex Injectable: Critical Supply Chain and Quality Control Implications for US Market

Accord Healthcare, Inc. initiated a Class III recall of Dodex Injectable (Cyanocobalamin Injection) USP due to subpotency. Manufactured by Intas Pharmaceuticals in India, this event highlights critical quality control challenges within global pharmaceutical supply chains. Procurement and regulatory teams must assess inventory impact and strengthen oversight of contract manufacturing to mitigate future disruptions.

REGULATORY INTELLIGENCE
2024-07-10

FDA Class II Recall: Little Moon Essentials' Crampy Belly Rub Hit by CGMP Deviations, Impacting US & Canadian Supply

Little Moon Essentials LLC has initiated a Class II recall for 788 jars of Crampy Belly Rub (Camphor 1.1%) due to Current Good Manufacturing Practice (CGMP) deviations. This voluntary action, impacting distribution across the USA and two retailers in Ontario, Canada, underscores critical compliance risks for procurement and supply chain leaders managing pharmaceutical and health product portfolios.

REGULATORY INTELLIGENCE
2024-07-10

FDA Class II Recall: The Harvard Drug Group's Venlafaxine HCl Extended-Release Capsules Fail Dissolution

The Harvard Drug Group LLC dba Major Pharmaceuticals initiated a Class II recall for Venlafaxine Hydrochloride extended-release capsules due to failed dissolution specifications. This event, involving 864 cartons manufactured by Cadila Healthcare, highlights critical quality control vulnerabilities for procurement and regulatory teams. Decision-makers must reassess supplier oversight and product quality assurance protocols to mitigate supply chain disruptions and patient safety risks.

REGULATORY INTELLIGENCE
2024-07-10

Dr. Reddy's Allopurinol Recall: Foreign Substance Prompts Class II Action, Supply Chain Scrutiny

Dr. Reddy's Laboratories, Inc. initiated a Class II recall (D-0583-2024) of 20,520 units of Allopurinol Tablets, USP 300mg, due to a foreign substance. This voluntary action, impacting distribution in IL, MS, and OH, underscores critical supply chain vulnerabilities and the imperative for robust quality control, demanding immediate attention from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-07-10

Medisca Inc. Recalls Budesonide USP Due to CGMP Deviations and Glass Particulates: Supply Chain Impact

Medisca Inc. has initiated a Class II recall for Budesonide, USP (Micronized) due to critical CGMP deviations and glass particulate contamination. This event, impacting 113 bottles distributed across the USA and Canada, necessitates immediate action from procurement and regulatory teams. It underscores the urgent need for robust supplier quality oversight and diversified API sourcing to mitigate supply chain disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2024-07-03

Pfizer Initiates Class II Recall of Buprenorphine Hydrochloride Injection Due to Sterility Concerns

Pfizer Inc. has initiated a Class II recall for 84,710 cartridges of Buprenorphine Hydrochloride Injection across the U.S. and Puerto Rico. This voluntary action, prompted by potential incomplete crimp seals and sterility assurance risks, demands immediate attention from procurement and regulatory teams. The event underscores critical supply chain vulnerabilities for essential medications and necessitates robust quality control assessments.

REGULATORY INTELLIGENCE
2024-07-03

Pacira Pharmaceuticals Recalls 40,517 Zilretta Kits Over Failed Dissolution Specifications

Pacira Pharmaceuticals, Inc. has initiated a Class II recall for 40,517 kits of Zilretta (triamcinolone acetonide extended-release injectable suspension) due to failed dissolution specifications. This voluntary, firm-initiated action impacts US nationwide distribution, necessitating immediate review of inventory and potential supply chain adjustments for buyers of intra-articular corticosteroids.

REGULATORY INTELLIGENCE
2024-07-03

Contract Pharmacal's Acetaminophen Recall Signals Persistent Quality Control Challenges

Contract Pharmacal Corporation has initiated a Class II voluntary recall of 14,616 bottles of Extra Strength Acetaminophen 500 MG Tablets due to discoloration. This event, prompted by brownish tablets, highlights ongoing quality control vulnerabilities for the Hauppauge, NY-based manufacturer, impacting supply chain stability for distributors like Major Pharmaceuticals and demanding immediate procurement re-evaluation.

REGULATORY INTELLIGENCE
2024-06-26

Lupin Pharmaceuticals Initiates Class II Recall of Cefixime Oral Suspension Due to Content Uniformity Failure

Lupin Pharmaceuticals Inc. executed a Class II voluntary recall for 3,552 bottles of Cefixime for Oral Suspension USP 200 mg/5 mL. This action, initiated on May 30, 2024, stemmed from the product failing content uniformity specifications. The recall, now terminated, highlights critical quality control challenges for this essential antibiotic, impacting US supply chains and demanding immediate attention from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-06-26

Eugia US LLC Initiates Class II Recall of Dexamethasone Sodium Phosphate Injection Over Impurity Specifications

Eugia US LLC has initiated a Class II recall of 70,125 vials of Dexamethasone Sodium Phosphate injection due to failed impurity specifications, specifically elevated sulfonic acid adduct levels. This event, impacting a critical corticosteroid distributed nationwide, necessitates immediate action from procurement and quality assurance teams to mitigate supply chain disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2024-06-26

FDA Class II Recall: MexHealth LLC's OSSOS-SANS Contains Undeclared Diclofenac and Methocarbamol

MexHealth LLC has initiated a Class II recall for OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets due to undeclared diclofenac and methocarbamol. This event underscores critical risks associated with unapproved drug products entering the supply chain, demanding heightened vigilance from procurement and regulatory teams to safeguard patient safety and ensure compliance.

REGULATORY INTELLIGENCE
2024-06-26

Breckenridge Pharmaceutical Initiates Class II Recall of Duloxetine Due to Nitrosamine Impurity

Breckenridge Pharmaceutical, Inc. has initiated a Class II recall for 165,678 bottles of Duloxetine Delayed-Release Capsules, 60mg, due to N-nitroso-duloxetine impurity exceeding FDA interim limits. This voluntary, firm-initiated action highlights critical contract manufacturing oversight and quality control challenges for generic drug supply chains, impacting nationwide distribution and requiring immediate attention from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-06-26

FDA Class II Recall: Consumer Product Partners' White Petrolatum Labeling Mix-Up Impacts Major Retailers

Consumer Product Partners, LLC initiated a Class II recall for 1,015 cases of White Petrolatum USP due to a critical labeling mix-up. Products, sold under Rite Aid, Kroger, Harris Teeter, and CVS brands, were mislabeled as 'pure' but contained lavender and chamomile. This event underscores significant supply chain and regulatory risks for procurement and quality assurance teams.

REGULATORY INTELLIGENCE
2024-06-19

FDA Class II Recall: Pacira's ZILRETTA Faces Nationwide Disruption Due to Stability Failure

Pacira Pharmaceuticals, Inc. has initiated a Class II nationwide recall of 43,768 kits of ZILRETTA (triamcinolone acetonide extended-release injectable suspension). This action, triggered by failed stability specifications, mandates immediate attention from procurement directors and supply chain VPs to mitigate disruption and assess the implications for product quality and patient access across the U.S.

REGULATORY INTELLIGENCE
2024-06-19

Imprimis NJOF, LLC Faces FDA Class II Recall for Ophthalmic Sterility Lapse, Impacting US Supply

Imprimis NJOF, LLC has initiated a Class II recall of its Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension due to lack of sterility assurance. This nationwide recall, affecting 4,280 boxes, highlights critical quality control vulnerabilities for compounded sterile products. Procurement and regulatory teams must immediately assess inventory and review supplier qualification processes to mitigate risks.

REGULATORY INTELLIGENCE
2024-06-19

Winder Laboratories Initiates Nationwide Class II Recall for Phenazopyridine HCl Due to Phenobarbital Mix-Up

Winder Laboratories, LLC has issued a Class II nationwide recall for Phenazopyridine HCl Tablets USP 100 mg due to a critical product mix-up, with bottles containing Phenobarbital tablets. This event, impacting 5,676 bottles, mandates immediate supply chain review and underscores the imperative for robust quality control and supplier diversification to mitigate significant regulatory and patient safety risks.

REGULATORY INTELLIGENCE
2024-06-12

Bryant Ranch Prepack Initiates Class III Recall of Cephalexin Oral Suspension Due to Labeling Error

Bryant Ranch Prepack, Inc. has initiated a Class III recall (D-0539-2024) for 190 bottles of Cephalexin for Oral Suspension, USP, due to a minor labeling discrepancy. This voluntary action, impacting nationwide distribution, underscores the critical need for meticulous quality control in pharmaceutical relabeling operations and highlights potential supply chain vulnerabilities for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-06-12

GlaxoSmithKline's Tivicay PD Recall: Labeling Error Impacts HIV Medication Supply Chain

GlaxoSmithKline LLC initiated a Class III recall for 463 cartons of Tivicay PD (dolutegravir sodium) 5mg tablets due to an incorrect carton expiration date. This event, now terminated, underscores critical pharmaceutical labeling and quality control vulnerabilities for procurement, regulatory, and supply chain leaders.

REGULATORY INTELLIGENCE
2024-06-12

Glenmark Pharmaceuticals Faces FDA Class II Recall for Rizatriptan Benzoate Due to Nitrosamine Impurity

Glenmark Pharmaceuticals Inc., USA has initiated a Class II recall (D-0535-2024) for 13,296 cartons of Rizatriptan Benzoate Orally Disintegrating Tablets nationwide. This action stems from N-Nitroso Desmethyl Rizatriptan impurity levels exceeding FDA acceptable limits, indicating critical CGMP deviations. Procurement and regulatory teams must assess supply chain stability and quality assurance protocols, particularly for products sourced internationally, given the ongoing regulatory scrutiny on nitrosamine impurities.

REGULATORY INTELLIGENCE
2024-06-12

FDA Class III Recall: Rising Pharma's Pregabalin Capsules Contaminated with Foreign Tablets, Impacting US Supply Chain

Rising Pharma Holdings, Inc. has initiated a voluntary Class III recall (D-0541-2024) for specific lots of Pregabalin Capsules 50mg distributed nationwide in the USA. This action stems from the discovery of a 20mg pantoprazole tablet within a bottle of Pregabalin, highlighting critical quality control failures at the manufacturing level. This event necessitates immediate supply chain risk assessment for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-06-12

Zydus Pharmaceuticals Initiates Class III Recall of Estradiol Transdermal System Due to Impurity Failures

Zydus Pharmaceuticals (USA) Inc. has initiated a Class III recall for 13,440 units of its Estradiol Transdermal System, USP, due to failed impurity and degradation specifications. This voluntary action, impacting lots M311202 and M311201, underscores the critical need for robust quality control in hormone therapy supply chains, prompting procurement and regulatory teams to reassess supplier compliance and sourcing strategies.

REGULATORY INTELLIGENCE
2024-06-12

Bryant Ranch Prepack Initiates Class III Recall of Cephalexin Oral Suspension Due to Critical Labeling Error

Bryant Ranch Prepack, Inc. has initiated a Class III nationwide recall (D-0538-2024) for 104 bottles of Cephalexin for Oral Suspension, USP, 250mg/5mL. This action stems from a critical labeling error where the back label incorrectly stated 5g of cephalexin monohydrate instead of the correct 10g per bottle. This event underscores the imperative for rigorous quality control in pharmaceutical relabeling operations.

REGULATORY INTELLIGENCE
2024-06-05

Genentech's Cathflo Activase Recall: Sterility Assurance Failure Highlights Critical Supply Chain Risks for Alteplase

Genentech initiated a Class II recall for 196,118 vials of Cathflo Activase (Alteplase) due to deformed stoppers, raising sterility assurance concerns. This voluntary recall, impacting nationwide U.S. distribution, underscores critical manufacturing quality risks for essential intravenous drugs. Procurement and regulatory teams must assess supply chain resilience and Genentech's corrective actions.

REGULATORY INTELLIGENCE
2024-06-05

FDA Class II Recall: Imprimis NJOF's Dexamethasone-Moxifloxacin-Ketorolac Vials Lacking Sterility Assurance

Imprimis NJOF, LLC has initiated a Class II nationwide recall of 38,060 vials of Dexamethasone-Moxifloxacin-Ketorolac intraocular injection due to a critical lack of sterility assurance. This event, originating from their Ledgewood, NJ facility, demands immediate action from procurement and regulatory teams to assess supply chain risks and ensure patient safety, given the product's direct ophthalmic application.

REGULATORY INTELLIGENCE
2024-06-05

Lupin Pharmaceuticals' Cefdinir Oral Suspension Recalled Due to Seal Integrity Issues: Supply Chain Alert

Lupin Pharmaceuticals Inc. initiated a Class II recall (D-0518-2024) for 51,006 bottles of Cefdinir for Oral Suspension USP, 250 mg/5 mL, distributed nationwide in the USA. The recall, terminated on April 29, 2025, stemmed from defective containers exhibiting a lack of seal integrity. This event underscores critical quality control challenges for procurement and regulatory teams managing generic antibiotic supplies.

REGULATORY INTELLIGENCE
2024-06-05

Regeneron's EYLEA (Aflibercept) Recall: Sterility Concerns Impact Ophthalmic Supply Chain

Regeneron Pharmaceuticals, Inc. initiated a Class II recall for 405,725 prefilled syringes of EYLEA (aflibercept) due to sterility concerns and syringe breakage from its Tarrytown, NY facility. This voluntary, nationwide recall, D-0531-2024, highlights critical quality control vulnerabilities impacting supply chain integrity for a key ophthalmic biologic. Procurement and regulatory teams must assess current inventory and supplier quality agreements.

REGULATORY INTELLIGENCE
2024-06-05

ARG Laboratories Initiates Nationwide Class II Recall of Pain Wizard Due to Active Ingredient Out-of-Specification and Violative Excipient Use

ARG Laboratories, Inc. has initiated a Class II nationwide recall for 3,504 units of its Pain Wizard roll-on. This action stems from the product being out of specification for active ingredients Camphor and Menthol, alongside the use of a violative grade of propylene glycol. Procurement and quality assurance teams must scrutinize supplier quality controls to mitigate similar risks and ensure compliance with FDA standards for excipients and active pharmaceutical ingredients.

REGULATORY INTELLIGENCE
2024-05-29

Dr. Reddy's Sirolimus Recall: Impurity Breach Triggers Class III Action, Demanding Supply Chain Review

Dr. Reddy's Laboratories, Inc. has initiated a Class III recall for Sirolimus Tablets 1mg across the U.S. due to failed impurity and degradation specifications. This event necessitates immediate action from procurement and regulatory teams to assess supply chain exposure and ensure product quality for this critical immunosuppressant, highlighting persistent challenges in generic pharmaceutical manufacturing oversight.

REGULATORY INTELLIGENCE
2024-05-29

FDA Class II Recall: Somerset Therapeutics' Haloperidol Decanoate Injection Contaminated

Somerset Therapeutics, LLC has initiated a Class II recall for Haloperidol Decanoate Injection due to water contamination in an oil-based product. This nationwide U.S. recall, affecting 5,578 units, underscores critical supply chain and quality control vulnerabilities for procurement directors and regulatory affairs heads. Proactive risk mitigation and enhanced supplier oversight are immediately required.

REGULATORY INTELLIGENCE
2024-05-29

Sun Pharma's XELPROS Recall: Particulate Matter Prompts Supply Chain Review for Latanoprost

Sun Pharmaceutical Industries, Inc. has initiated a voluntary Class III recall of 35,069 bottles of XELPROS (latanoprost ophthalmic emulsion) 0.005% due to out-of-specification particulate matter. This event, impacting distribution in Texas and Pennsylvania, necessitates immediate action from procurement and regulatory teams to assess supply chain vulnerabilities and ensure patient safety for this critical glaucoma medication.

REGULATORY INTELLIGENCE
2024-05-22

Lupin Pharmaceuticals Initiates Class II Recall of Cefdinir Oral Suspension Due to Foreign Material

Lupin Pharmaceuticals Inc. has initiated a Class II recall for 17,070 bottles of Cefdinir for Oral Suspension USP 250 mg/5 mL due to foreign material contamination. This voluntary, nationwide recall impacts a critical generic antibiotic, requiring immediate action from procurement and supply chain leaders to assess inventory and mitigate potential disruptions.

REGULATORY INTELLIGENCE
2024-05-22

Pharma Nobis LLC Initiates Nationwide Class II Recall of Magnesium Citrate Oral Solution Due to Microbial Contamination

Pharma Nobis LLC has initiated a Class II recall (D-0500-2024) of 120,830 units of Magnesium Citrate Oral Solution distributed nationwide, citing microbial contamination by Acetobacter nitrogenifigens. This event necessitates immediate action for procurement directors and supply chain VPs to assess inventory, manage potential shortages, and re-evaluate supplier quality controls for non-sterile pharmaceutical products.

REGULATORY INTELLIGENCE
2024-05-22

FDA Class II Recall: Gordon Laboratories' Salicylic Acid Wart Remover Pulled Over cGMP Deviations

Dercher Enterprises, Inc., DBA Gordon Laboratories initiated a Class II recall of 5,247 jars of Gordofilm Wart Remover (salicylic acid 16.7% USP) due to cGMP deviations. This nationwide US distribution event, impacting multiple lots, signals critical quality control failures. Procurement and regulatory teams must assess supply chain risks and heightened FDA scrutiny for topical pharmaceutical formulations.

REGULATORY INTELLIGENCE
2024-05-22

Sagent Pharmaceuticals Initiates Nationwide Class II Recall of Methylprednisolone Acetate Injectable Suspension Due to Particulate Matter

Sagent Pharmaceuticals has initiated a nationwide Class II recall for 14,360 vials of Methylprednisolone Acetate Injectable Suspension due to black particulate matter. This voluntary action, affecting product manufactured in India, necessitates immediate supply chain and procurement review. Regulatory affairs must assess compliance, while business development monitors market shifts for this critical corticosteroid.

REGULATORY INTELLIGENCE
2024-05-22

Stop Clopez Corp's Schwinnng Recall: FDA Flags Unapproved Drug Masquerading as Herbal Supplement

Stop Clopez Corp initiated a Class I recall for its Schwinnng Herbal Dietary Supplement Capsules, distributed worldwide via amazon.com, due to marketing without FDA drug approval. This event highlights critical regulatory non-compliance, as the product was deemed an unapproved new drug. Procurement and regulatory teams must scrutinize suppliers of 'dietary supplements' for undeclared drug components or unapproved drug claims, mitigating significant market access and reputational risks.

REGULATORY INTELLIGENCE
2024-05-15

FDA Class II Recall: RemedyRepack's TraMADol HCl Contamination Exposes Critical Repackaging Risks

RemedyRepack Inc.'s Class II recall of 23,970 TraMADol HCl 50 mg tablets due to baclofen contamination highlights severe quality control deficiencies in pharmaceutical repackaging. This incident, coupled with a prior recall for dissolution failure, necessitates immediate review of supplier qualification processes by procurement directors and supply chain VPs to mitigate significant patient safety and business risks.

REGULATORY INTELLIGENCE
2024-05-15

FDC Limited's Timolol Maleate Ophthalmic Solution Recalled Due to Container Defect, Highlighting Supply Chain Risks

FDC Limited initiated a Class II recall of 382,104 units of Timolol Maleate Ophthalmic Solution due to a defective container, impacting distributor Rising Pharma Holdings, Inc. This event from the Aurangabad, India facility underscores critical quality control needs for sterile products, demanding enhanced vigilance from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-05-15

Dr. Reddy's Sapropterin Dihydrochloride Class I Recall: Sub-Potency Triggers Urgent Supply Chain Review

Dr. Reddy's Laboratories, Inc. initiated a Class I recall of 2402 cartons of Sapropterin Dihydrochloride Powder for Oral Solution 100mg due to sub-potency and discoloration. This event, originating from manufacturing in India, necessitates immediate action from procurement and regulatory teams to assess supply continuity and patient safety risks across the U.S. market.

REGULATORY INTELLIGENCE
2024-05-15

Sun Pharma's Amphotericin B Recall: Assay Failure Impacts US Supply Chain

Sun Pharmaceutical Industries, Inc. has initiated a Class II recall of 11,016 vials of Amphotericin B Liposome for Injection due to out-of-specification assay results. This voluntary action, originating from its Halol, India facility, impacts nationwide distribution in the United States, necessitating immediate review by procurement and regulatory teams to mitigate potential supply disruptions for this critical antifungal medication.

REGULATORY INTELLIGENCE
2024-05-15

FDA Class II Recall: Rubicon Research's Tramadol Contamination Raises Supply Chain Concerns

Rubicon Research Private Limited has initiated a Class II recall for Tramadol Hydrochloride Tablets due to baclofen contamination. This event, impacting 2,592 bottles distributed by Advagen Pharma Limited nationwide, signals critical quality control failures at the Ambarnath, India facility. Procurement and supply chain leaders must immediately assess exposure, diversify sourcing, and enhance supplier due diligence to mitigate disruption and patient safety risks.

REGULATORY INTELLIGENCE
2024-05-15

FDA Class II Recall: Aurolife Pharma's Discolored Clorazepate Dipotassium Tablets Impact Supply

Aurolife Pharma LLC faces an FDA Class II recall for 6,909 bottles of Clorazepate Dipotassium Tablets due to discoloration. This event, initiated by distributor Aurobindo Pharma USA Inc., signals critical quality control deficiencies. Procurement and regulatory teams must assess supply chain exposure and accelerate alternative sourcing strategies to mitigate potential market disruption for this essential benzodiazepine.

REGULATORY INTELLIGENCE
2024-05-15

Breckenridge Pharmaceutical Recalls Duloxetine Due to N-nitroso Impurity: Supply Chain and Regulatory Implications

Breckenridge Pharmaceutical, Inc. has initiated a Class II nationwide recall of Duloxetine Delayed-Release Capsules, USP, 60 mg. This action, stemming from N-nitroso-duloxetine impurity levels exceeding FDA limits and CGMP deviations at manufacturer Towa Pharmaceutical Europe, S.L., demands immediate attention from procurement and regulatory teams to mitigate supply disruption and ensure compliance.

REGULATORY INTELLIGENCE
2024-05-08

Imprimis NJOF, LLC Initiates Class II Recall of Subpotent Ophthalmic Solution, Raising Quality Control Concerns

Imprimis NJOF, LLC has initiated a U.S. nationwide Class II recall for 3,320 bottles of its Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution due to subpotency. This FDA-mandated action highlights critical quality control failures, demanding immediate attention from procurement, regulatory, and supply chain leaders to mitigate patient safety risks and ensure product efficacy.

REGULATORY INTELLIGENCE
2024-05-08

Viatris Recalls Valacyclovir Tablets Over Missing Imprints: Supply Chain and Regulatory Implications

Viatris Inc. has initiated a Class III recall of 143,230 bottles of Valacyclovir Tablets USP, 500 mg, due to missing tablet imprints. This voluntary action, impacting nationwide U.S. distribution, highlights critical quality control vulnerabilities for procurement and regulatory teams. Decision-makers must assess supply chain resilience for Valacyclovir and monitor Viatris's ongoing compliance, given its history of product recalls.

REGULATORY INTELLIGENCE
2024-05-08

FDA Mandates Class II Recall for Amneal's Methylergonovine Maleate Over Critical Dissolution Failures

Amneal Pharmaceuticals of New York, LLC initiated a Class II recall for 2,784 bottles of Methylergonovine Maleate Tablets, USP, 0.2mg, due to failed dissolution specifications. This nationwide US recall, impacting lot BJ01922A, highlights critical quality control deficiencies. Procurement and regulatory teams must scrutinize supplier quality and ensure robust dissolution testing protocols to mitigate supply chain risks for this essential post-partum medication.

REGULATORY INTELLIGENCE
2024-05-08

Hikma Injectables USA Inc. Initiates Nationwide Fentanyl Recall Over Barcode Labeling Error

Hikma Injectables USA Inc. has completed a nationwide Class III recall of 1,895 bags of Fentanyl 1000mcg/100mL Injection due to a wrong barcode on the labeling. This voluntary, firm-initiated action highlights critical quality control vulnerabilities in pharmaceutical packaging, posing risks to patient safety and supply chain integrity for this Schedule II controlled substance.

REGULATORY INTELLIGENCE
2024-05-01

FDA Class II Recall: Nomax Inc.'s Fluorescein Sodium Ophthalmic Strips Fail USP Impurity Specifications

Nomax Inc. has initiated a Class II recall (D-0462-2024) for 15,056 cartons of GLOSTRIPS, Fluorescein Sodium Ophthalmic Strips, due to active pharmaceutical ingredient (API) non-compliance with USP monograph specifications for unspecified impurities. This voluntary nationwide recall highlights critical quality control failures in API manufacturing, posing immediate supply chain risks for ophthalmic diagnostic products and underscoring the need for rigorous supplier qualification.

REGULATORY INTELLIGENCE
2024-05-01

Cipla USA Initiates Class II Recall for Ipratropium Bromide and Albuterol Sulfate Inhalation Solution Due to Short-Fill

Cipla USA, Inc. has initiated a Class II recall (D-0471-2024) for Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP due to short-fill complaints. This voluntary, firm-initiated action, impacting 59,244 packs nationwide, highlights critical quality control vulnerabilities for respiratory therapeutics. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate supply chain risks.

REGULATORY INTELLIGENCE
2024-05-01

FA Online Inc Class I Recall: Undeclared Sildenafil in ForeverMen Capsules Highlights Critical Regulatory Risks

FA Online Inc initiated a Class I recall (D-0470-2024) for its ForeverMen Natural Energy Boost Capsules, distributed nationwide via Amazon. The product was found to contain undeclared sildenafil, an active pharmaceutical ingredient, rendering it an unapproved drug. This event underscores critical risks in supply chain oversight and regulatory compliance for firms marketing dietary supplements, demanding rigorous due diligence from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-05-01

FDA Class I Recall: Pyramids Wholesale Inc. Pulls "Flower Power" Over Undeclared Sildenafil and Tadalafil

Pyramids Wholesale Inc. initiated a Class I FDA recall (D-0450-2024) for its "Flower Power, CBD infused Female Enhancement" product due to undeclared sildenafil and/or tadalafil, marketed without an approved NDA/ANDA. This event underscores critical supply chain and regulatory compliance risks for businesses. Procurement and regulatory affairs must enhance due diligence to avoid sourcing or distributing adulterated products, ensuring robust quality control and adherence to FDA approval pathways.

REGULATORY INTELLIGENCE
2024-05-01

FDA Class I Recall: Aruba Aloe Balm's Lidocaine Gel Contaminated with Methanol, Impacting US Supply

Aruba Aloe Balm N.V. has initiated a Class I recall for 9,625 bottles of its Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, distributed nationwide in the USA. The recall, D-0459-2024, stems from chemical contamination: the product was manufactured with ethanol API containing methanol. This poses significant health risks, necessitating immediate action from procurement and regulatory teams to assess supply chain integrity.

REGULATORY INTELLIGENCE
2024-05-01

FDA Class II Recall: Dr. Reddy's Quality Program Lapse Triggers Minolira (Minocycline Hydrochloride) Recall by EPI Health

EPI Health, LLC initiated a Class II recall of minolira (minocycline hydrochloride) extended-release tablets due to a critical CGMP deviation by manufacturer Dr. Reddy's Laboratories Limited, India. The discontinuation of a quality program raises significant concerns for product integrity and supply chain reliability, necessitating immediate action for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-04-24

Specialty Process Labs LLC Initiates Class II Recall of Thyroid, USP API Due to Failed Stability Specifications

Specialty Process Labs LLC has initiated a Class II recall for 217 units of S.P Labs, Thyroid, USP, an API for manufacturing, due to failed stability specifications. This event, impacting U.S. nationwide distribution, necessitates immediate action from procurement and regulatory teams to assess supply chain risks and ensure product quality for downstream formulations.

REGULATORY INTELLIGENCE
2024-04-17

NATCO Pharma's Lansoprazole Recall: CGMP Deviations Trigger Nationwide US Market Disruption

NATCO Pharma Limited initiated a Class II recall (D-0438-2024) for 30 bottles of Lansoprazole Delayed-Release Capsules USP, 15 mg, due to CGMP deviations at its Kothur, India, facility. This event, now terminated, underscores critical quality control vulnerabilities for procurement and regulatory teams. Supply chain executives must assess the impact on product availability and re-evaluate supplier qualification protocols to mitigate future disruptions.

REGULATORY INTELLIGENCE
2024-04-10

FDA Class II Recall: B. Braun Medical's Lactated Ringer's Injection Faces Sterility Concerns

B. Braun Medical Inc. has initiated a Class II recall for 7,800 bags of Lactated Ringer's Injection USP due to potential leakage compromising sterility. This nationwide recall, initiated on March 22, 2024, highlights critical quality control vulnerabilities. Procurement and supply chain leaders must assess current inventory and B. Braun's remediation efforts to mitigate supply disruptions and patient safety risks.

REGULATORY INTELLIGENCE
2024-04-10

IntegraDose Fentanyl Citrate Recall: Sterility Failure Poses Critical Supply Chain and Patient Safety Risks

IntegraDose Compounding Services LLC initiated a nationwide Class II recall of 187 cassettes of fentaNYL Citrate 2,500 mcg/50mL in Sterile Water due to leaking bags, indicating a critical lack of sterility assurance. This event mandates immediate action for procurement directors to secure alternative opioid analgesic supplies and for regulatory affairs heads to scrutinize supplier quality systems, mitigating patient safety risks and supply chain disruptions.

REGULATORY INTELLIGENCE
2024-04-10

FDA Class II Recall: SSM St. Clare Health Center's Phenylephrine HCl Syringes Lack Sterility Assurance

SSM Health Care St. Louis DBA SSM St. Clare Health Center initiated a Class II recall for 11,798 syringes of compounded Phenylephrine HCl due to a lack of sterility assurance. This critical compliance failure, stemming from inadequate process validation, impacts procurement and regulatory strategies for intravenous drugs, highlighting the imperative for robust quality systems in compounding facilities to mitigate patient risk and ensure supply chain integrity.

REGULATORY INTELLIGENCE
2024-04-10

FDA Class III Recall: X-Gen Pharmaceuticals' Cyclophosphamide Labeling Error Impacts Oncology Supply

X-Gen Pharmaceuticals Inc. initiated a Class III recall (D-0434-2024) for 1332 vials of Cyclophosphamide for Injection, USP, due to a critical labeling error. The package insert incorrectly stated the reconstituted product's concentration as '20 mg per vial' instead of '20 mg per mL'. This event underscores the imperative for robust quality control in pharmaceutical labeling, directly impacting patient safety and supply chain integrity.

REGULATORY INTELLIGENCE
2024-04-10

Glenmark Pharmaceuticals Initiates Class II Recall of Diltiazem Hydrochloride Capsules Due to Dissolution Failure

Glenmark Pharmaceuticals Inc., USA has initiated a Class II recall for 6,528 bottles of Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, due to failed dissolution specifications. This nationwide recall, stemming from a long-term stability study, necessitates immediate action for procurement and supply chain leaders to mitigate disruption and ensure patient safety.

REGULATORY INTELLIGENCE
2024-04-03

SCA Pharmaceuticals Recalls PHENYLephrine HCl Injection Due to Sterility Concerns, Impacting US Supply Chains

SCA Pharmaceuticals initiated a Class II recall for 8,050 syringes of PHENYLephrine HCl Injection from its Windsor, CT facility, citing lack of sterility assurance. This nationwide action, now terminated, underscores critical quality control vulnerabilities in sterile drug manufacturing. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate similar supply disruptions and patient safety risks.

REGULATORY INTELLIGENCE
2024-04-03

FDA Class I Recall: Par Sterile Products' Treprostinil Injection Impacted by Particulate Matter

Par Sterile Products LLC has initiated a Class I recall for 466 vials of Treprostinil Injection (Lot#: 57014) due to particulate matter, impacting nationwide U.S. distribution. This high-severity event demands immediate attention from procurement and regulatory teams to assess supply chain integrity and patient safety risks associated with this critical cardiovascular drug. Decision-makers must evaluate current inventory and potential sourcing disruptions.

REGULATORY INTELLIGENCE
2024-04-03

Apothecus Pharmaceutical Corp. Faces Class II Recall of VCF Contraceptive Film Due to cGMP Deviations

Apothecus Pharmaceutical Corp. initiated a Class II recall for 17,280 cartons of VCF Vaginal Contraceptive Film (nonoxynol-9) due to cGMP deviations. This nationwide U.S. recall, D-0427-2024, highlights critical compliance gaps. For procurement and regulatory leaders, this underscores the imperative for stringent supplier qualification and robust quality oversight to mitigate supply chain disruptions and ensure product integrity.

REGULATORY INTELLIGENCE
2024-03-27

Eugia US LLC Initiates Class II Recall for Nicardipine Hydrochloride Injection Due to Organic Impurities

Eugia US LLC has initiated a Class II recall for 43,920 vials of Nicardipine Hydrochloride Injection, USP, due to out-of-specification organic impurities. This nationwide U.S. recall, impacting lot 3NC22019, signals critical quality control failures. Procurement and supply chain leaders must immediately assess inventory, identify potential shortfalls, and evaluate supplier qualification processes to mitigate disruption and ensure patient safety.

REGULATORY INTELLIGENCE
2024-03-27

Super Chill Products' Class I Recall of Tianeptine Elixir Highlights Critical Unapproved Drug Risks

Super Chill Products initiated a Class I recall (D-0393-2024) for 3,573 bottles of Neptune's Fix, Tianeptine Elixir, distributed nationwide. The FDA cited marketing without approved NDA/ANDA, as tianeptine lacks U.S. medical approval. This event underscores critical regulatory risks for procurement and regulatory affairs, demanding rigorous due diligence on all distributed products to avoid unapproved substances and ensure compliance within the global chemical and life sciences supply chain.

REGULATORY INTELLIGENCE
2024-03-20

Global Corporation Initiates Class II Recall of Broncochem Cold & Flu Syrup Kids Due to API Stability Failures

Global Corporation has initiated a Class II recall of 9,831 bottles of Broncochem Cold & Flu Syrup Kids due to stability testing failures for Phenylephrine HCl and/or Chlorpheniramine Maleate. This voluntary action, impacting nationwide U.S. distribution, underscores critical risks in contract manufacturing oversight and API quality control. Procurement and regulatory teams must reassess supplier qualification and post-market surveillance protocols to mitigate similar supply chain disruptions.

REGULATORY INTELLIGENCE
2024-03-20

Optikem International's Sterile Eye Drops Recalled Nationwide Over Sterility Assurance Failure

Optikem International, Inc. has initiated a Class II nationwide recall of 24,216 bottles of TRP Natural Eyes Floaters Relief, Sterile Eye Drops, due to a lack of sterility assurance. This event underscores critical supply chain vulnerabilities and mandates immediate review of sterile product manufacturing protocols for procurement and regulatory teams across the industry.

REGULATORY INTELLIGENCE
2024-03-20

FDA Regulatory Findings Highlight Stability Failures for Global Corporation's Broncochem Cold & Tea

Global Corporation faces significant FDA regulatory findings concerning Broncochem Cold & Tea, stemming from critical stability testing failures for Phenylephrine HCl and/or Chlorpheniramine Maleate. This Class II recall, impacting 2,345 boxes nationwide, underscores severe quality control vulnerabilities. Procurement and regulatory teams must assess their supply chain resilience for these common APIs and prepare for heightened FDA oversight and potential further enforcement actions.

REGULATORY INTELLIGENCE
2024-03-20

FDA Class II Recall: Thea Pharma's Betimol Ophthalmic Solution Faces Sterility and Container Integrity Issues

Thea Pharma Inc. initiated a Class II recall for Betimol (timolol ophthalmic solution) due to sterility, volume, and container closure issues. This event underscores critical quality control vulnerabilities in sterile manufacturing, demanding heightened vigilance from procurement, regulatory, and supply chain leaders to mitigate patient safety risks and ensure product integrity across the pharmaceutical industry.

REGULATORY INTELLIGENCE
2024-03-20

McKesson Recall of Pfizer's Bicillin L-A Highlights Critical Distributor Storage Compliance Gaps

McKesson Medical-Surgical Inc. initiated a Class II recall (D-0373-2024) of 70 vials of Pfizer's Bicillin L-A (Penicillin G Benzathine) due to storage outside label specifications. This event, now terminated, underscores critical cGMP compliance risks within pharmaceutical distribution, urging procurement and supply chain leaders to enhance due diligence on distributor storage protocols to safeguard product integrity and patient safety.

REGULATORY INTELLIGENCE
2024-03-20

B. Braun Medical Inc. Recalls Potassium Chloride Injection Over Sterility Concerns: Supply Chain Implications

B. Braun Medical Inc. has initiated a Class II recall (D-0370-2024) for 22,752 bags of Potassium Chloride for Injection Concentrate USP due to sterility assurance concerns from pinholes in packaging. This event, now terminated, highlights critical quality control vulnerabilities in parenteral drug manufacturing. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate supply chain disruptions for essential hospital-grade pharmaceuticals.

REGULATORY INTELLIGENCE
2024-03-20

Eugia US LLC's Tobramycin for Injection Recalled by FDA Over Stability Failure: Critical Supply Chain Implications

Eugia US LLC initiated a Class II recall (D-0385-2024) for 1,160 vials of Tobramycin for Injection, USP, due to failed water determination stability specifications. This event, impacting nationwide distribution, highlights critical quality control vulnerabilities in globally sourced sterile injectables. Decision-makers must reassess supplier qualification, quality oversight for international manufacturing, and strategic sourcing to mitigate supply chain risks for essential antibiotics.

REGULATORY INTELLIGENCE
2024-03-20

Sun Pharmaceutical Industries Initiates Class II Recall of Febuxostat Tablets Due to Microbial Contamination

Sun Pharmaceutical Industries has initiated a Class II recall of 7,488 bottles of Febuxostat Tablets 80mg due to microbial contamination in manufacturing equipment. This event, impacting nationwide distribution, signals recurring quality control challenges for Sun Pharma, necessitating immediate supply chain risk assessment and diversification strategies for procurement and regulatory teams managing Xanthine Oxidase Inhibitors.

REGULATORY INTELLIGENCE
2024-03-20

McKesson Recall of Infuvite Adult Multiple Vitamins Highlights Critical Distribution Storage Compliance Gaps

McKesson Medical-Surgical Inc. initiated a Class II recall (D-0372-2024) for 70 vials of Infuvite Adult Multiple vitamins injection due to storage outside label specifications. This terminated recall highlights critical cGMP compliance gaps within pharmaceutical distribution networks. Procurement and regulatory teams must scrutinize distributor storage protocols to mitigate supply chain disruptions and ensure product integrity for essential medicines.

REGULATORY INTELLIGENCE
2024-03-13

Marlex Pharmaceuticals Faces FDA Class III Recall for Clindamycin Phosphate Due to Container Leakage, Highlighting CMO Quality Risks

Marlex Pharmaceuticals faces an FDA Class III recall for 45,875 bottles of Clindamycin Phosphate Topical Solution, manufactured by Contract Pharmaceuticals Limited Canada. The recall, initiated due to container leakage and out-of-specification weight, impacts nationwide U.S. and Puerto Rico distribution. This event underscores critical vulnerabilities in contract manufacturing oversight and the imperative for robust container integrity testing for pharmaceutical products.

REGULATORY INTELLIGENCE
2024-03-13

Eugia US LLC Methylprednisolone Acetate Recall: Dissolution Failure Exposes Supply Chain Risks

Eugia US LLC has initiated a Class II recall for Methylprednisolone Acetate Injectable Suspension due to failed dissolution specifications, impacting 10,080 vials distributed across OH, TN, LA, MS. This event highlights critical supply chain vulnerabilities for essential corticosteroids, necessitating immediate action from procurement and regulatory teams to assess exposure and identify qualified alternative suppliers to ensure continuity of patient care and market supply.

REGULATORY INTELLIGENCE
2024-03-13

Stason Pharmaceuticals' Mercaptopurine Tablets Recall Terminated: Supply Chain Implications

Stason Pharmaceuticals' voluntary Class III recall of 54,131 bottles of Mercaptopurine Tablets, USP 50 mg, due to failed dissolution specifications, has been terminated by the FDA. This event, impacting Quinn Pharmaceuticals' supply, underscores the need for robust quality oversight in contract manufacturing. Procurement and supply chain leaders must verify Stason's corrective actions to ensure future supply integrity for this critical chemotherapy drug.

REGULATORY INTELLIGENCE
2024-03-06

Brassica Pharma Faces Second FDA Recall for Eye Ointment Sterility, Escalating Supply Chain Risk

Brassica Pharma Pvt Ltd faces a Class II FDA recall for 159,334 units of CVS Health Lubricant Eye Ointment due to a lack of sterility assurance. This follows a similar recall for Equate Eye Ointment, signaling systemic quality control deficiencies at its Thane, India facility. Procurement and regulatory teams must reassess Brassica Pharma as a supplier, given the recurring sterility concerns impacting critical ophthalmic products distributed in the U.S.

REGULATORY INTELLIGENCE
2024-03-06

FDA Class II Recall: Golden State Medical Supply's Fluticasone Propionate Nasal Spray Pulled Over Burkholderia cepacia Complex Contamination

Golden State Medical Supply initiated a nationwide Class II recall of 59,712 bottles of Fluticasone Propionate Nasal Spray due to suspected *Burkholderia cepacia complex* contamination, stemming from significant CGMP deviations at manufacturer Apotek Inc. This event signals critical regulatory non-compliance, necessitating immediate supply chain review for procurement directors and heightened quality assurance for all stakeholders.

REGULATORY INTELLIGENCE
2024-03-06

FDA Class II Recall: Brassica Pharma's Equate Eye Ointment Faces Sterility Assurance Failure, Impacting Walmart Supply Chain

Brassica Pharma Pvt Ltd faces an FDA Class II recall for 315,842 units of Equate Lubricant Eye Ointment due to sterility assurance failures. This impacts Walmart's supply chain and necessitates immediate action for procurement and regulatory teams. Businesses must assess their supplier qualification processes, identify alternative sterile ophthalmic product manufacturers, and mitigate potential supply disruptions from Indian facilities.

REGULATORY INTELLIGENCE
2024-03-06

FDA Mandates Class II Recall for Seatex LLC Hand Sanitizers Over CGMP Deviations at Texas Facility

Seatex LLC has initiated a Class II recall for its PROBLEND E3 and All-In-One Foaming Hand Sanitizers following FDA inspection findings of Current Good Manufacturing Practice (CGMP) deviations at its Rosenberg, TX facility. This event underscores the critical need for robust quality systems in OTC drug manufacturing, impacting supply chain continuity and regulatory compliance for distributors and procurement teams.

REGULATORY INTELLIGENCE
2024-03-06

Leiters Health Faces Class II Recall for Particulate Matter in Lidocaine/Phenylephrine Vials Amidst Prior Class I Violations

Leiters Health has initiated a Class II recall for 40,890 vials of Lidocaine HCL 1% and PHENYLephrine HCL 1.5% due to glass delamination. This event, originating from their Englewood, CO facility, highlights persistent quality control challenges, following two prior Class I recalls for superpotent Vancomycin HCl. Procurement and regulatory teams must assess immediate supply risks and Leiters' long-term compliance trajectory.

REGULATORY INTELLIGENCE
2024-02-28

Alpha Aromatics Recalls 676 Gallons of Hand Sanitizer Over Critical CGMP Deviations

Alpha Aromatics initiated a Class II recall of 676 gallons of Pure Care Foaming Mint Hand Sanitizer 62% due to CGMP Deviations. This voluntary, firm-initiated action, impacting two accounts in NC and MI, underscores persistent quality control risks in drug product manufacturing. Procurement and regulatory teams must scrutinize supplier compliance to mitigate supply chain disruptions and ensure product integrity.

REGULATORY INTELLIGENCE
2024-02-28

Bestco LLC Recalls CVS Health Cough Drops Over Glass and Silicone Particulates: A Critical CGMP Lapse

Bestco LLC initiated a Class II recall for CVS Health Cherry Cough Drops due to CGMP deviations, specifically potential glass and silicone particulates. This event, terminated February 2026, highlights critical quality control vulnerabilities in OTC drug manufacturing. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate similar supply chain disruptions and product integrity risks.

REGULATORY INTELLIGENCE
2024-02-28

McKesson Corporation Initiates Class II Recall of CABTREO Topical Gel Due to Temperature Excursion

McKesson Corporation has voluntarily recalled 42 units of CABTREO Topical Gel (Lot: 7001796) nationwide due to storage outside labeled temperature requirements. This Class II recall, initiated February 12, 2024, and terminated October 1, 2024, highlights critical CGMP deviations in distribution. Procurement and supply chain leaders must scrutinize cold chain integrity and distributor quality agreements to mitigate similar risks.

REGULATORY INTELLIGENCE
2024-02-28

Amneal Pharmaceuticals Recalls Oseltamivir Phosphate Due to Impurity Failures, Highlighting Generic Antiviral Supply Risks

Amneal Pharmaceuticals NY LLC initiated a Class II recall of 46,037 bottles of Oseltamivir Phosphate for Oral Suspension due to failed impurity specifications. This firm-initiated action, now terminated, underscores critical quality control challenges in generic antiviral manufacturing. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate future supply disruptions for essential medicines.

REGULATORY INTELLIGENCE
2024-02-28

Mallinckrodt's Terlivaz (Terlipressin) Faces Class II FDA Recall Over Shipping Temperature Excursion

Mallinckrodt Hospital Products Inc. has initiated a Class II FDA recall for 421 vials of Terlivaz (terlipressin for injection) distributed nationwide. This action, D-0341-2024, stems from cGMP deviations, specifically a temperature excursion during shipping from the manufacturer to the distributor. Procurement and regulatory teams must assess immediate supply chain impacts for this critical vasopressin receptor agonist.

REGULATORY INTELLIGENCE
2024-02-28

FDA Issues Class I Recall for Neptune's Fix Tianeptine Products: Critical Regulatory Risk for Unapproved Substances

Neptune Resources, LLC faces an FDA Class I recall (D-0335-2024) for its Neptune's Fix Tianeptine Tablets Extended Relief, due to marketing an unapproved drug. This event underscores severe regulatory risks for firms distributing non-FDA-approved substances, demanding immediate review of product portfolios and stringent compliance protocols to mitigate significant commercial and legal exposure.

REGULATORY INTELLIGENCE
2024-02-28

FDA Class II Recall: Micro Labs Limited's Clobazam Tablets Face CGMP Deviations, Prompting Supply Chain Scrutiny

Micro Labs Limited has initiated a Class II recall for 24,768 bottles of Clobazam Tablets 10mg due to CGMP deviations, specifically out-of-specification residual solvents. This event, impacting nationwide U.S. distribution, signals significant quality control vulnerabilities for the Indian manufacturer. Procurement and regulatory teams must assess immediate supply risks and potential long-term implications for sourcing this critical benzodiazepine.

REGULATORY INTELLIGENCE
2024-02-21

Teva Pharmaceuticals Initiates Nationwide Class III Recall for Discolored Nortrel Oral Contraceptives

Teva Pharmaceuticals USA, Inc. has initiated a voluntary Class III nationwide recall for specific lots of its Nortrel (norethindrone and ethinyl estradiol) tablets due to discoloration. This event, impacting 12,916 cartons, highlights the critical need for robust quality control in pharmaceutical manufacturing and necessitates immediate supply chain assessment by procurement and regulatory teams to mitigate potential disruptions.

REGULATORY INTELLIGENCE
2024-02-21

IntegraDose Vasopressin Recall: Sub-Potency Exposes Minnesota Healthcare Providers to Supply Risk and Regulatory Scrutiny

IntegraDose Compounding Services LLC has initiated a Class II recall for 1,299 syringes of Vasopressin due to sub-potency, failing to maintain strength through its expiration date. This event, coupled with a prior Fentanyl Citrate recall, signals systemic quality control issues. Procurement and regulatory teams must assess immediate supply chain risks for compounded drugs in Minnesota and scrutinize IntegraDose's compliance trajectory.

REGULATORY INTELLIGENCE
2024-02-21

FDA Class II Recall: The Harvard Drug Group LLC's HydrALAZINE Impurity Prompts Nationwide Distribution Halt

The Harvard Drug Group LLC initiated a Class II recall for HydrALAZINE Hydrochloride Tablets due to impurity issues, impacting 8,198 units nationwide. This event underscores critical supply chain vulnerabilities and the imperative for robust quality control in pharmaceutical distribution. Procurement and regulatory teams must reassess supplier qualification and stability testing protocols to mitigate similar future disruptions.

REGULATORY INTELLIGENCE
2024-02-14

OMEZA LLC Initiates Class II Recall of Omeza Skin Protectant Due to CGMP Deviations

OMEZA LLC has voluntarily recalled 1,210 vials of Omeza Skin Protectant Gel (Lot: 19123 4-1) due to Current Good Manufacturing Practice (CGMP) deviations. This Class II, firm-initiated recall, distributed US nationwide, underscores critical regulatory compliance challenges. Supply chain and regulatory teams must scrutinize supplier quality systems to mitigate similar disruptions and ensure product integrity.

REGULATORY INTELLIGENCE
2024-02-14

FDA Oversight Triggers Voluntary Recall for Medline Industries' Miconazole Nitrate Cream Over False 'Paraben Free' Labeling

Medline Industries, LP initiated a Class II recall for 1,786 tubes of its Medline Remedy Clinical TREAT Antifungal Cream due to mislabeling as "Paraben Free" despite containing parabens. This FDA-classified action highlights critical compliance gaps in labeling and ingredient verification. Procurement and regulatory teams must reassess supplier quality systems to mitigate similar risks and ensure product integrity.

REGULATORY INTELLIGENCE
2024-02-14

FDA Class I Recall: Kilitch Healthcare's Dry Eye Relief Pulled Due to Non-Sterility Risk

Kilitch Healthcare India Limited has initiated a Class I recall for 137,544 bottles of Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) distributed by Target Corporation. The critical reason for this firm-initiated action is non-sterility, posing significant health risks to consumers. This event underscores the imperative for robust quality control in ophthalmic product manufacturing and supply chain vigilance.

REGULATORY INTELLIGENCE
2024-02-14

FDA Issues Class I Recall for Kilitch Healthcare's Non-Sterile Polyvinyl Alcohol Eye Drops

Kilitch Healthcare India Limited faces a Class I FDA recall for 1.49 million bottles of Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops due to non-sterility. This event, initiated November 13, 2023, highlights critical supply chain and quality control vulnerabilities for procurement and regulatory teams sourcing ophthalmic products from India, demanding immediate reassessment of supplier qualification and risk mitigation strategies.

REGULATORY INTELLIGENCE
2024-02-14

FDA Class II Recall: American Health Packaging's Febuxostat Impacted by CGMP Deviations

Amerisource Health Services LLC initiated a Class II recall for American Health Packaging's Febuxostat Tablets due to CGMP deviations. This impacts 1,932 cartons distributed nationwide, signaling critical quality system failures. Procurement and regulatory teams must assess supply chain integrity and monitor remediation efforts for this essential Xanthine Oxidase Inhibitor.

REGULATORY INTELLIGENCE
2024-02-14

Dr. Reddy's Glimepiride Tablets Recalled Nationwide Over Tablet Misprint: Supply Chain Implications

Dr. Reddy's Laboratories, Inc. has initiated a Class III recall of 14,425 bottles of Glimepiride Tablets, USP 1mg, across the U.S. due to a tablet misprint. This voluntary action, stemming from its Indian manufacturing arm, highlights critical quality control vulnerabilities. Procurement and regulatory teams must assess supplier quality systems and potential supply disruptions for this essential diabetes medication.

REGULATORY INTELLIGENCE
2024-02-14

Kilitch Healthcare India Limited Initiates Class I Recall of Non-Sterile Dry Eye Relief Ophthalmic Solution

Kilitch Healthcare India Limited initiated a Class I recall for 23,208 bottles of Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%) due to non-sterility. This voluntary action, impacting nationwide U.S. distribution, highlights critical supply chain vulnerabilities for ophthalmic products. Procurement and regulatory teams must reassess sterility assurance protocols and supplier qualification, particularly for contract manufacturing relationships involving high-risk sterile formulations.

REGULATORY INTELLIGENCE
2024-02-14

Amneal Pharmaceuticals Initiates Class II Recall of Phenoxybenzamine Hydrochloride Capsules Due to Unknown Impurity

Amneal Pharmaceuticals of New York, LLC, has executed a Class II recall for Phenoxybenzamine Hydrochloride Capsules, USP 10mg, due to an out-of-specification unknown impurity. This nationwide recall, impacting 858 bottles, necessitates immediate supply chain and quality assurance reviews for procurement directors and regulatory affairs heads, highlighting critical supplier quality control risks for this essential molecule.

REGULATORY INTELLIGENCE
2024-02-07

Lupin Pharmaceuticals Recalls Subpotent Rifampin Capsules Manufactured in India, Impacting US Supply Chains

Lupin Pharmaceuticals Inc. initiated a Class II recall for 15,576 bottles of Rifampin Capsules USP 150mg due to subpotency and failed impurity specifications. Manufactured by Lupin Limited in India, this impacts 32 US wholesalers and 156 distribution sites. The recall, D-0283-2024, was terminated on August 27, 2024, but highlights critical quality control vulnerabilities for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-02-07

Azurity Pharmaceuticals' Class I Dextroamphetamine Sulfate Recall Highlights Critical Labeling Risks

Azurity Pharmaceuticals initiated a Class I recall for 4,662 bottles of Zenzedi (Dextroamphetamine Sulfate) CII Tablets due to a labeling mix-up. This high-severity event, now terminated, underscores critical quality control deficiencies in pharmaceutical packaging. Procurement, regulatory, and supply chain leaders must enhance due diligence on contract manufacturers and internal labeling processes to mitigate similar risks with controlled substances.

REGULATORY INTELLIGENCE
2024-02-07

FDA Class I Recall: Leiters Health's Superpotent Vancomycin HCl Poses Significant Supply Chain Risk

Leiters Health has initiated a Class I recall (D-0281-2024) for 10,152 IV bags of VANCOmycin HCl PF 1.25g due to a semi-automated filling system malfunction causing double doses. This superpotent drug risk from their Englewood, CO facility demands immediate action from procurement and regulatory teams to mitigate patient safety concerns and secure alternative supplies for this critical antibiotic.

REGULATORY INTELLIGENCE
2024-02-07

FDA Class II Recall: Teva Pharmaceuticals' Budesonide Extended-Release Tablets Fail Dissolution Specifications

Teva Pharmaceuticals USA, Inc. has initiated a Class II recall for 10,672 bottles of Budesonide Extended-Release Tablets 9mg due to failed dissolution specifications. This event, stemming from manufacturing at Actavis Laboratories FL, Inc., signals potential efficacy issues and mandates immediate review of supply chain resilience for procurement and regulatory teams reliant on Teva's generic corticosteroid products.

REGULATORY INTELLIGENCE
2024-02-07

FDA Class II Recall: Golden State Medical Supply's Budesonide Extended-Release Tablets Fail Dissolution Specifications

Golden State Medical Supply Inc. initiated a Class II recall for 108 bottles of Budesonide Extended-Release Tablets, 9 mg, due to failed dissolution specifications. This voluntary, firm-initiated action, impacting only Illinois, was terminated on March 20, 2025. Procurement and regulatory teams should note the specific quality deviation and its resolution, though the limited distribution minimizes broader supply chain disruption.

REGULATORY INTELLIGENCE
2024-02-07

FDA Class I Recall: Leiters Health's Superpotent Vancomycin HCl Poses Critical Supply Chain Risk

Leiters Health has initiated a Class I recall of 7,548 IV bags of VANCOmycin HCl PF 1.5g due to a superpotent drug issue from a malfunctioning semi-automated filling system. This FDA action, D-0282-2024, signals a critical manufacturing quality control failure, demanding immediate attention from procurement and regulatory teams to mitigate supply chain disruption and patient safety risks.

REGULATORY INTELLIGENCE
2024-02-07

Den-Mat Holdings Recalls 10,103 Units of Hydrogen Peroxide Oral Rinse Over CGMP Deviations

Den-Mat Holdings, LLC has initiated a Class II recall for 10,103 units of Hydrogen Peroxide Oral Rinse due to Current Good Manufacturing Practice (CGMP) deviations, impacting product specifications. This event, recall number D-0287-2024, necessitates immediate action from procurement and supply chain leaders to assess inventory and mitigate potential market disruptions.

REGULATORY INTELLIGENCE
2024-02-07

FDA Class II Recall: American Health Packaging's Rifampin Capsules Fail Impurity Specifications

American Health Packaging faces commercial implications following a Class II FDA recall of 1,568 cartons of Rifampin Capsules USP 150 mg due to failed impurities/degradation specifications. This nationwide recall, initiated by Amerisource Health Services LLC, highlights critical quality control vulnerabilities. Procurement and supply chain leaders must assess current sourcing strategies and identify qualified alternative suppliers to mitigate potential supply disruptions for this essential antibacterial.

REGULATORY INTELLIGENCE
2024-01-31

Sun Pharmaceutical Industries Initiates Class II Recall of Mesalamine Tablets Due to Microbial Contamination

Sun Pharmaceutical Industries Inc. has initiated a Class II recall of 10,690 bottles of Mesalamine Delayed-Release Tablets, USP 1.2 g, due to microbial contamination found in manufacturing equipment. This event, stemming from their Dadra, India facility, necessitates immediate assessment by procurement, supply chain, and regulatory teams to mitigate potential supply disruptions and ensure patient safety for this critical inflammatory bowel disease medication.

REGULATORY INTELLIGENCE
2024-01-31

Pfizer Faces Class I Recall for Bleomycin Injection Due to Glass Particulate Matter, Raising Supply Chain Concerns

Pfizer has initiated a Class I recall for Bleomycin for Injection, USP, impacting 3,546 vials across the USA, Netherlands, and Libya, due to glass particulate matter. This event, classified for serious health risks, underscores recurring quality control challenges for Pfizer, demanding immediate attention from procurement and regulatory teams to mitigate supply disruptions and patient safety concerns.

REGULATORY INTELLIGENCE
2024-01-31

Haleon US Holdings LLC Initiates Class I Recall of Robitussin Honey CF Max Nighttime Adult Due to Microbial Contamination

Haleon US Holdings LLC has initiated a Class I recall for 21,900 bottles of Robitussin Honey CF Max Nighttime Adult nationwide due to microbial contamination. This presents a high risk of serious adverse health consequences, demanding immediate action from procurement, regulatory, and supply chain leaders to mitigate disruption and ensure patient safety.

REGULATORY INTELLIGENCE
2024-01-31

Strides Pharma Initiates Nationwide Recall of Methoxsalen Capsules Due to Dissolution Failures

Strides Pharma Inc. initiated a Class II recall for 396 bottles of Methoxsalen Capsules, USP 10mg, distributed nationwide in the USA. The recall, due to failed dissolution specifications, highlights critical quality control challenges for the manufacturer, Strides Pharma Science Ltd. This event necessitates immediate review of supply chain integrity and quality assurance protocols for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-01-24

Pfizer Initiates Class I Recall of Sodium Bicarbonate Injection Due to Glass Particulate Matter, Triggering Supply Chain Scrutiny

Pfizer Inc. has initiated a Class I recall for 34,000 cartons of 4.2% Sodium Bicarbonate Injection, USP, due to glass particulate matter. This severe regulatory action, distributed nationwide in the USA and Puerto Rico, poses significant patient safety risks and demands immediate attention from procurement, regulatory, and supply chain leaders to mitigate disruption and ensure compliance.

REGULATORY INTELLIGENCE
2024-01-24

FDA Class II Recall: Par Sterile Products' Vasostrict Superpotency Poses Supply Chain Risk

Par Sterile Products LLC has initiated a nationwide Class II recall for Vasostrict (vasopressin) injection due to superpotency. This event, impacting 1,721 cartons, signals critical quality control failures in manufacturing stability testing. Procurement and supply chain leaders must assess immediate inventory, potential shortages, and the broader implications for injectable drug sourcing and patient safety.

REGULATORY INTELLIGENCE
2024-01-24

Pharma Nobis LLC Initiates Class II Recall for Magnesium Citrate Due to Acetobacter nitrogenifigens Contamination

Pharma Nobis LLC has initiated a Class II recall for 24,684 bottles of Magnesium Citrate Saline Laxative due to Acetobacter nitrogenifigens bacterial contamination. This voluntary, firm-initiated action, distributed nationwide by AmerisourceBergen, underscores critical quality control vulnerabilities in non-sterile pharmaceutical manufacturing. Procurement and regulatory teams must reassess supplier qualification and microbial testing protocols for oral solutions.

REGULATORY INTELLIGENCE
2024-01-24

Pharma Nobis LLC Initiates Class II Recall of Magnesium Citrate Oral Solution Due to Microbial Contamination

Pharma Nobis LLC has initiated a Class II recall for 53,268 bottles of Freskaro Magnesium Citrate Oral Solution due to Acetobacter nitrogenifigens contamination. This voluntary action, originating from its Texarkana, TX facility, underscores critical quality control vulnerabilities in non-sterile drug manufacturing. Procurement and regulatory teams must reassess supplier qualification and internal cGMP adherence to mitigate supply chain disruption and ensure patient safety.

REGULATORY INTELLIGENCE
2024-01-24

FDA Terminates P&G Secret OUTLAST Recall: Benzene Contamination Highlights Critical CGMP Gaps

The Procter & Gamble Company's Class II recall of Secret OUTLAST Dry Spray, due to benzene contamination and CGMP deviations, has been terminated. This event underscores persistent quality control challenges within consumer health product manufacturing. Procurement directors and regulatory affairs heads must reinforce robust supplier qualification and analytical testing protocols to mitigate similar supply chain risks.

REGULATORY INTELLIGENCE
2024-01-24

CVS Health Magnesium Citrate Oral Solution Recalled Nationwide Due to Acetobacter Nitrogenifigens Contamination

CVS Pharmacy, Inc. faces a nationwide Class II recall of 13,344 bottles of its Magnesium Citrate Oral Solution, initiated by Pharma Nobis LLC, due to contamination with Acetobacter nitrogenifigens bacteria. This event underscores critical quality control vulnerabilities in non-sterile drug manufacturing, impacting supply chain integrity and consumer trust for CVS Pharmacy, Inc. and its partners.

REGULATORY INTELLIGENCE
2024-01-24

FDA Class I Recall: Benzene Contamination Triggers Urgent Action for Insight Pharmaceuticals' Americaine Spray

Insight Pharmaceuticals LLC faces an FDA Class I recall for 34,704 cans of Americaine Benzocaine Topical Anesthetic Spray due to benzene contamination. This critical event, initiated December 21, 2023, necessitates immediate action from procurement and regulatory teams. Businesses must reassess supplier quality for topical APIs and finished products, especially those manufactured internationally, to mitigate severe health risks and maintain compliance.

REGULATORY INTELLIGENCE
2024-01-17

Dr. Reddy's Tacrolimus Capsules Recalled Nationwide by FDA Due to Dosage Mix-Up: Supply Chain Implications

Dr. Reddy's Laboratories, Inc. initiated a Class II recall for Tacrolimus Capsules, USP 1mg, distributed US nationwide. The recall, prompted by a 0.5 mg capsule found in a 1 mg bottle, highlights critical quality control vulnerabilities from its India manufacturing facility. Procurement and regulatory teams must assess supply chain integrity and patient safety risks for this essential immunosuppressant.

REGULATORY INTELLIGENCE
2024-01-17

FDA Issues Class I Recall for InvaGen's Vigabatrin Oral Solution Due to Critical Packaging Defect

InvaGen Pharmaceuticals initiated a Class I recall for 1,240 boxes of Vigabatrin for Oral Solution, USP 500 mg, due to defective packaging causing powder leakage. This event, impacting nationwide US distribution, necessitates immediate action from procurement and regulatory teams to ensure patient safety and maintain supply chain integrity for this critical anti-epileptic agent.

REGULATORY INTELLIGENCE
2024-01-17

Lupin Pharmaceuticals Recalls Desloratadine Tablets Over N-Nitroso Impurity: Critical CGMP Implications for Supply Chains

Lupin Pharmaceuticals Inc. initiated a Class II recall for Desloratadine Tablets USP 5mg due to N-Nitroso Desloratadine impurity exceeding acceptable limits, stemming from CGMP deviations. This event underscores critical supply chain and regulatory risks for procurement and regulatory affairs teams. Proactive impurity detection, robust quality systems, and diversified sourcing strategies are essential to mitigate disruption and ensure patient safety amidst heightened FDA scrutiny on nitrosamine contaminants.

REGULATORY INTELLIGENCE
2024-01-10

Seaway Pharma Inc. Initiates Class II Recall for Oxymetazoline Hydrochloride Nasal Spray Over CGMP Deviations

Seaway Pharma Inc. has initiated a Class II recall for 7,992 bottles of Oxymetazoline hydrochloride 0.05% nasal spray due to potential microbial contamination in manufacturing water. While final products tested clean, this CGMP deviation highlights critical quality control risks for procurement and regulatory teams. Supply chain VPs should assess exposure in Michigan and Pennsylvania, while business development executives note the ongoing FDA scrutiny on manufacturing processes across the OTC drug sector.

REGULATORY INTELLIGENCE
2024-01-10

Azurity Pharmaceuticals Recalls Eprontia (Topiramate) Oral Solution Over Impurity C Exceedance

Azurity Pharmaceuticals initiated a Class III recall of 2,220 bottles of Eprontia (topiramate) oral solution nationwide due to out-of-specification levels of Impurity C (4,5-desisopropylidene topiramate) found during stability testing. This voluntary action, terminated on April 24, 2024, underscores the critical importance of robust quality control and stability programs for pharmaceutical manufacturers.

REGULATORY INTELLIGENCE
2024-01-03

Dicyclomine Hydrochloride Recall Signals Critical CGMP Gaps for Actavis, Teva, and Cardinal Healthcare

A Class II recall of Dicyclomine Hydrochloride Tablets, USP 20 mg, initiated by Cardinal Healthcare for Teva Pharmaceuticals USA, highlights critical CGMP deviations. Products were exposed to temperatures outside labeled storage conditions, raising concerns about product integrity. This event underscores the urgent need for procurement and regulatory teams to reassess quality oversight across complex pharmaceutical supply chains.

REGULATORY INTELLIGENCE
2024-01-03

FDA Class II Recall: Teva Pharmaceuticals' Warfarin Sodium Affected by Cardinal Healthcare Storage Deviations

Teva Pharmaceuticals USA, Inc.'s Warfarin Sodium Tablets faced a Class II recall initiated by CARDINAL HEALTHCARE due to CGMP deviations involving temperature excursions during storage. This event, now terminated, underscores critical supply chain vulnerabilities for procurement and regulatory teams, demanding rigorous oversight of distributor storage protocols for sensitive pharmaceuticals.

REGULATORY INTELLIGENCE
2024-01-03

FDA Class II Recall: Cipla USA Inc.'s Ipratropium Bromide and Albuterol Sulfate Inhalation Solution Affected by CGMP Deviations

Cipla USA Inc. faces regulatory scrutiny following a Class II recall of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, distributed nationwide. The recall, initiated by Cardinal Healthcare, cites CGMP deviations due to product exposure to temperatures outside labeled storage conditions. This event underscores critical supply chain vulnerabilities and the imperative for robust quality management systems across all pharmaceutical stakeholders, impacting procurement and regulatory strategies.

REGULATORY INTELLIGENCE
2024-01-03

FDA Terminates Class II Recall for Avet Pharmaceuticals' HydrALAZINE Hydrochloride Due to Temperature Excursions

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. faced a Class II recall for HydrALAZINE Hydrochloride Tablets due to CGMP deviations involving temperature excursions during distribution by CARDINAL HEALTHCARE in Dublin, OH. This terminated recall, though small (2 units), highlights critical supply chain vulnerabilities. Procurement and regulatory teams must reinforce stringent storage protocols and quality agreements across all partners to mitigate risks to product integrity and ensure patient safety.

REGULATORY INTELLIGENCE
2024-01-03

Critical Class I Recall: TCP HRB ACQUISITION LLC's Sure Anti-perspirant Contaminated with Benzene, Impacting US and Canada

TCP HRB ACQUISITION LLC has initiated a Class I recall for 0.5 million units of Sure Unscented Anti-perspirant Deodorant Aerosol across the US and Canada due to benzene contamination. This high-severity event, identified on February 16, 2022, demands immediate action from procurement and regulatory teams to assess supply chain vulnerabilities, enhance quality control, and mitigate significant market disruption risks from similar chemical contamination issues.

REGULATORY INTELLIGENCE
2024-01-03

Cardinal Healthcare's Lansoprazole Recall Highlights Critical Supply Chain Temperature Control Failures

Cardinal Healthcare initiated a Class II recall for FIRST LANSOPRAZOLE PT 3MG/ML due to CGMP deviations and temperature excursions. This nationwide USA recall, terminated September 29, 2024, underscores persistent challenges in pharmaceutical cold chain integrity. Decision-makers must scrutinize distributor quality systems to mitigate similar supply chain risks.

REGULATORY INTELLIGENCE
2024-01-03

Sandoz Enoxaparin Sodium Recall: FDA Class II Action Highlights Critical CGMP Temperature Excursion Risks

Sandoz Inc's Enoxaparin Sodium Injection faced a Class II recall, initiated by Cardinal Healthcare, due to critical CGMP deviations from temperature excursions. This event, now terminated, underscores persistent cold chain vulnerabilities impacting pharmaceutical stability and efficacy. Procurement and regulatory teams must scrutinize supplier quality systems and distribution protocols to mitigate similar risks across their supply networks, ensuring patient safety and supply continuity.

REGULATORY INTELLIGENCE
2024-01-03

FDA Class II Recall: Allergan's ARMOUR THYROID Impacted by Cardinal Healthcare's Temperature Excursion CGMP Deviations

Allergan, Inc.'s ARMOUR THYROID (thyroid tablets, USP) faced a Class II recall, D-0168-2024, initiated by distributor CARDINAL HEALTHCARE due to CGMP deviations involving temperature excursions. This event, terminated on September 29, 2024, underscores critical vulnerabilities in pharmaceutical distribution networks, demanding heightened scrutiny from procurement, regulatory, and supply chain leaders on storage compliance.

REGULATORY INTELLIGENCE
2024-01-03

Solco Healthcare's Donepezil HCl Recall Highlights Critical Temperature Excursion Risks in Pharmaceutical Supply Chains

Solco Healthcare US, LLC's Donepezil HCl Tablets, 5 mg, faced a Class II recall initiated by Cardinal Health due to temperature excursions impacting product integrity. This event, now terminated, underscores persistent CGMP compliance challenges in pharmaceutical distribution. Procurement and supply chain leaders must scrutinize third-party logistics partners and implement robust temperature monitoring protocols to mitigate similar risks for critical neurological medications.

REGULATORY INTELLIGENCE
2024-01-03

Cardinal Health Initiates Class II Recall of Aspirin Due to Temperature Excursions

CARDINAL HEALTHCARE initiated a Class II recall for 81 mg Aspirin due to temperature excursions, indicating CGMP deviations. This event, coupled with a prior similar recall, signals potential systemic issues in their temperature-controlled logistics. Procurement and regulatory teams must scrutinize distribution quality, reassess supplier qualifications, and enhance monitoring to mitigate significant supply chain risks.

REGULATORY INTELLIGENCE
2024-01-03

Cardinal Health Doxycycline Recall Highlights Critical Temperature Control Gaps in Pharmaceutical Distribution

Cardinal Health's Class II recall of Doxycycline Capsules, USP 100 mg, due to temperature excursions, underscores persistent challenges in pharmaceutical cold chain management. This event, initiated by Cardinal Health, highlights the critical need for robust CGMP compliance in distribution, impacting procurement strategies and regulatory oversight for essential antibiotics. Decision-makers must reassess distributor qualification and monitoring protocols.

REGULATORY INTELLIGENCE
2024-01-03

FDA Class II Recall: Teva's Estradiol Tablets Impacted by Cardinal Health's CGMP Storage Deviations

Cardinal Health initiated a Class II recall for Teva Pharmaceuticals' Estradiol Tablets (ANDA040197) due to critical CGMP deviations involving temperature excursions. This event, impacting nationwide USA distribution, underscores significant supply chain vulnerabilities for essential hormone therapies. Procurement directors must diversify Estradiol sourcing, while regulatory affairs heads must strengthen temperature control protocols to mitigate risks and ensure compliance, safeguarding patient access and business continuity.

REGULATORY INTELLIGENCE
2024-01-03

FDA Class II Recall: Amneal Pharmaceuticals' Aripiprazole Tablets Face CGMP Deviation

Amneal Pharmaceuticals faced a Class II recall (D-0167-2024) for 5 mg Aripiprazole Tablets due to CGMP deviations involving temperature excursions during distribution. Initiated by Cardinal Healthcare for two units, this event, now terminated, underscores critical supply chain vulnerabilities. Decision-makers must scrutinize distributor compliance and robust quality systems to mitigate similar risks for temperature-sensitive pharmaceuticals like Aripiprazole.

REGULATORY INTELLIGENCE
2024-01-03

Cardinal Healthcare Amoxicillin Recall: CGMP Deviation Exposes Supply Chain Temperature Risks

Cardinal Healthcare initiated a Class II recall (D-0166-2024) for two units of Sandoz-manufactured Amoxicillin Tablets, 875MG, due to CGMP deviations involving temperature excursions. This terminated recall, though small, underscores the critical importance of maintaining strict cold chain integrity and robust quality systems across the pharmaceutical supply chain, impacting procurement and regulatory compliance strategies for distributors nationwide.

REGULATORY INTELLIGENCE
2024-01-03

FDA Class II Recall: Cardinal Health's Tiotropium Bromide Distribution Impacted by CGMP Deviations

Cardinal Health initiated a Class II recall for 5 units of SPIRIVA HANDIHALER (tiotropium bromide) due to CGMP deviations involving temperature excursions. This terminated recall underscores the critical need for robust cold chain management and quality assurance protocols within pharmaceutical distribution networks, directly impacting procurement and regulatory compliance strategies for global chemical and life sciences firms.

REGULATORY INTELLIGENCE
2024-01-03

GlaxoSmithKline Recalls ANORO ELLIPTA Due to Particle Size Issue: Implications for Respiratory Drug Supply

GlaxoSmithKline LLC initiated a Class III recall for 67,508 ANORO ELLIPTA inhalers from its Durham, NC facility due to out-of-specification coarse particle mass for umeclidinium. This event, now terminated, highlights critical quality control challenges in inhalation drug manufacturing. Procurement and supply chain leaders must reinforce quality oversight and diversification strategies for respiratory therapies to mitigate similar disruptions.

REGULATORY INTELLIGENCE
2024-01-03

AnazaoHealth Corporation Initiates Nationwide Class II Recall of Thiamine HCl/Pyridoxine HCl Injection Due to Particulate Matter

AnazaoHealth Corporation initiated a nationwide Class II recall (D-0204-2024) for 3,363 vials of Thiamine HCl/Pyridoxine HCl Injection Solution due to particulate matter. This event, terminated by the FDA, underscores critical quality control failures in sterile compounding. Procurement and regulatory teams must scrutinize injectable suppliers, reinforcing robust qualification processes to mitigate patient safety risks and supply chain disruptions from similar quality lapses.

REGULATORY INTELLIGENCE
2024-01-03

FDA Class II Recall: Legacy Pharmaceutical Packaging Faces Scrutiny Over Sertraline CGMP Deviations

Legacy Pharmaceutical Packaging LLC initiated a Class II recall for 161,664 bottles of Sertraline Tablets, USP 100 mg, due to inadequate line clearance and potential product commingling at its Earth City, MO facility. This event highlights critical CGMP compliance risks for contract packagers, directly impacting Cipla USA, Inc. and Wal-Mart's supply chains in California and Arkansas, necessitating immediate risk mitigation by procurement and regulatory teams.

REGULATORY INTELLIGENCE
2024-01-03

FDA Class II Recall: Cardinal Health's Fluticasone Propionate Nasal Spray Due to Temperature Excursions

Cardinal Health initiated a Class II recall for Fluticasone Propionate Nasal Spray (ANDA077538) due to CGMP deviations involving temperature excursions. This voluntary action, impacting 6 units manufactured for Apotex Corp., highlights critical vulnerabilities in pharmaceutical storage and distribution networks. Decision-makers must reassess temperature control protocols to mitigate similar supply chain risks.

REGULATORY INTELLIGENCE
2024-01-03

Cardinal Healthcare's Metoprolol Succinate Recall Highlights Critical CGMP Gaps in Pharmaceutical Distribution

CARDINAL HEALTHCARE initiated a Class II recall of Metoprolol Succinate Extended-Release Tablets due to CGMP deviations, specifically temperature excursions. This event, now terminated, underscores critical vulnerabilities in pharmaceutical supply chain integrity. For procurement and regulatory teams, it emphasizes the imperative for robust temperature monitoring and stringent quality oversight across all distribution partners to mitigate patient safety risks and ensure product efficacy.

REGULATORY INTELLIGENCE
2024-01-03

Cardinal Healthcare Initiates Class II Recall for Ricola Throat Drops Due to CGMP Storage Deviations

Cardinal Healthcare initiated a Class II recall (D-0195-2024) for 2 units of Ricola CherryHoney Herb Throat Drops due to CGMP deviations involving temperature excursions. This event, though small in scale, highlights critical vulnerabilities in pharmaceutical distribution networks. Decision-makers must reassess their quality agreements and temperature control protocols with third-party logistics providers to mitigate similar product integrity risks and ensure regulatory compliance.

REGULATORY INTELLIGENCE
2021-06-02

Cardinal Health Inc. Faces FDA Class II Recall for XIGDUO XR Due to Storage Temperature Excursions

Cardinal Health Inc. faced a Class II recall for 664 bottles of XIGDUO XR (dapagliflozin/metformin HCl) due to CGMP deviations involving temperature excursions during storage across Florida, Georgia, and South Carolina. This terminated 2024-06-17 recall underscores the critical need for robust temperature control in pharmaceutical distribution, impacting supply chain integrity and regulatory compliance for all stakeholders.

REGULATORY INTELLIGENCE
2020-12-30

Fresenius Kabi's Sensorcaine-MPF Recall: Subpotent Epinephrine Exposes Critical Quality Control Gaps

Fresenius Kabi USA, LLC initiated a Class II recall for 4411 trays of Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) due to subpotent epinephrine. This nationwide recall, D-0172-2021, highlights critical quality control failures impacting patient safety and supply chain reliability. Procurement directors must assess supplier quality systems, while regulatory affairs heads should monitor Fresenius Kabi's remediation efforts to mitigate future supply disruptions.

REGULATORY INTELLIGENCE
2020-12-30

Akebia Therapeutics' Auryxia (Ferric Citrate) Recall Signals Persistent CGMP Compliance Risks

Akebia Therapeutics initiated a Class II voluntary recall of 2,170 bottles of Auryxia (ferric citrate) tablets, 210 mg, Lot 9062, due to CGMP Deviations. This nationwide distribution event, terminated September 1, 2021, underscores persistent quality control challenges in pharmaceutical manufacturing. Procurement and regulatory teams must enhance supplier vigilance and supply chain resilience against such compliance risks.

REGULATORY INTELLIGENCE
2020-12-23

Zydus Pharmaceuticals' Lansoprazole Recall: Dissolution Failures Expose Generic Drug Supply Chain Vulnerabilities

Zydus Pharmaceuticals USA Inc. initiated a Class II voluntary recall of 15,144 cartons of Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg due to failed dissolution specifications. This event, now terminated, underscores critical quality control challenges in generic drug manufacturing. Procurement and regulatory teams must scrutinize supplier quality systems, particularly for distributed products, to mitigate supply chain disruptions and ensure patient safety and market compliance.

REGULATORY INTELLIGENCE
2020-12-23

Taro Pharmaceuticals Recalls Kroger Clotrimazole Cream Due to Degradation Impurity

Taro Pharmaceuticals U.S.A., Inc. initiated a Class II recall for 133,452 tubes of Kroger Athlete's Foot Cream (Clotrimazole Cream USP, 1%) due to an unknown degradation impurity exceeding specification limits. This voluntary, firm-initiated recall, distributed nationwide in the USA and Canada, highlights critical quality control challenges for over-the-counter antifungal products. The recall, D-0154-2021, was terminated on February 21, 2024.

REGULATORY INTELLIGENCE
2020-12-23

Biogen's Vumerity Recall: Dissolution Failures Highlight Critical Pharmaceutical Quality Control Risks

Biogen Inc. initiated a Class II recall for 5,307 bottles of Vumerity (diroximel fumarate) due to failed dissolution specifications. This event, terminated by the FDA, underscores the persistent quality control challenges in pharmaceutical manufacturing. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate supply chain disruptions and ensure product efficacy for patients.

REGULATORY INTELLIGENCE
2020-12-23

AVKARE Inc. Faces Class I Recall for Trazodone-Sildenafil Mix-up at Third-Party Facility

AVKARE Inc. initiated a Class I recall for 14,368 bottles of TraZODONE Hydrochloride Tablets 100 mg due to an inadvertent sildenafil mix-up at a third-party facility. This event underscores critical vulnerabilities in outsourced manufacturing and demands immediate attention from procurement and regulatory leaders to reassess quality control and supply chain resilience.

REGULATORY INTELLIGENCE
2020-12-23

Simex Logistics' Class II Recall: Subpotent Hand Sanitizer Exposes Supply Chain Vulnerabilities

Simex Logistics SA de CV initiated a Class II recall of 1,800 bottles of CitruGel Hand Sanitizer due to subpotency, impacting US states. This event underscores critical quality control gaps in international supply chains, demanding heightened vigilance from procurement and regulatory teams. The recall, terminated in 2023, highlights persistent challenges in ensuring product efficacy from overseas manufacturers.

REGULATORY INTELLIGENCE
2020-12-23

Advanced Nutriceuticals Recalls BPC-157 Due to Critical Sterility Assurance Lapses

Advanced Nutriceuticals, LLC has initiated a Class II recall for BPC-157 vials due to a critical lack of sterility assurance in its production processes. This voluntary action impacts multiple lots distributed across seven U.S. states, underscoring significant quality control deficiencies. Procurement and regulatory teams must scrutinize supplier qualification and aseptic manufacturing protocols to mitigate similar supply chain risks.

REGULATORY INTELLIGENCE
2020-12-16

Asiaticon Hand Sanitizer Recall: CGMP Failures Highlight International Sourcing Risks

Asiaticon, SA de CV's V-Klean Hand Sanitizer Gel Alcohol 70% faced a Class II recall (D-0116-2021) due to critical Current Good Manufacturing Practices (CGMPs) deficiencies at its Ciudad De Mexico facility. This voluntary recall, involving 111,500 units distributed in Texas, underscores the persistent regulatory risks associated with outsourced manufacturing of over-the-counter (OTC) products. Procurement and regulatory teams must intensify supplier qualification and oversight, particularly for international partners, to mitigate supply chain disruptions and ensure product quality.

CLINICAL & PIPELINE
2020-12-16

TEVA PHARMS USA Gains FDA Approval for Generic EFINACONAZOLE 10% Topical Solution, Reshaping Antifungal Market Dynamics

TEVA PHARMS USA has secured FDA approval for its generic EFINACONAZOLE 10% topical solution (ANDA211827) on December 16, 2020. This approval introduces a therapeutically equivalent alternative, intensifying competition in the antifungal market. Procurement directors should evaluate TEVA as a new supplier, while supply chain VPs must anticipate potential price erosion and adjust sourcing strategies for this key molecule.

REGULATORY INTELLIGENCE
2020-12-16

Novocol Pharmaceutical's Mepivacaine Hydrochloride Recall: Label Mix-Up Exposes Critical Supply Chain Vulnerabilities

Novocol Pharmaceutical of Canada, Inc. initiated a Class III recall of 15,398 cartridges of Scandonest 3% Plain (Mepivacaine Hydrochloride) due to a label mix-up. This voluntary action, impacting U.S. distribution, underscores critical quality control vulnerabilities for procurement and regulatory teams. The terminated recall highlights the imperative for robust supplier oversight and stringent labeling verification to mitigate supply chain disruption and patient safety risks.

REGULATORY INTELLIGENCE
2020-12-16

Shilpa Medicare Azacitidine Recall: CGMP Deviations Highlight Critical India-US Supply Chain Risks

Shilpa Medicare Limited initiated a Class II recall of 35,931 vials of Azacitidine for Injection due to CGMP deviations at its Polepally, India facility. This event, distributed by Armas Pharmaceuticals Inc. in the U.S., underscores critical supply chain vulnerabilities for essential oncology drugs. Procurement and regulatory teams must scrutinize supplier quality systems and diversify sourcing to mitigate disruption and ensure patient safety.

CLINICAL & PIPELINE
2020-12-15

RISING Secures FDA Approval for Sevelamer Hydrochloride Generic, Marketing Status Discontinued

RISING secured FDA approval on December 15, 2020, for its Abbreviated New Drug Application (ANDA) for Sevelamer Hydrochloride 400mg and 800mg tablets. Despite this regulatory milestone, the marketing status for both approved products is listed as "Discontinued." This indicates RISING is not actively marketing these generic Sevelamer Hydrochloride formulations, impacting immediate market competition and procurement strategies for this phosphate binder.

REGULATORY INTELLIGENCE
2020-12-09

FDA Class I Recall: Torrent Pharmaceuticals' Anagrelide Capsules Fail Dissolution, Triggering Supply Chain Review

Torrent Pharmaceuticals Limited's Class I recall of Anagrelide Capsules due to failed dissolution specifications underscores critical supply chain and regulatory risks. This event, impacting 2,496 bottles nationwide, necessitates immediate review of sourcing strategies for essential medicines. Procurement and regulatory leaders must assess supplier quality systems and diversify supply to mitigate future disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2020-12-09

Golden State Medical Supply's Aripiprazole Recall: Dissolution Failures Expose Quality Control Gaps

Golden State Medical Supply Inc. initiated a Class II nationwide recall of 11,922 bottles of Aripiprazole Tablets, 15 mg, due to failed dissolution specifications. This event, stemming from a critical quality control lapse, underscores the imperative for robust supplier qualification and stringent in-process testing for pharmaceutical packagers. Procurement and regulatory teams must reassess their due diligence protocols to mitigate similar supply chain risks.

REGULATORY INTELLIGENCE
2020-12-02

Heritage Pharmaceuticals' Felodipine Recall: Impurity Failures Highlight Global Supply Chain Risks

Heritage Pharmaceuticals Inc. initiated a Class III recall for Felodipine Extended Release Tablets due to out-of-specification impurity levels of Felodipine Related compound A. This voluntary, nationwide recall, now terminated, highlights critical quality control vulnerabilities for pharmaceutical distributors sourcing from overseas manufacturers. Procurement and regulatory teams must scrutinize supplier quality systems, especially for products manufactured in India, to mitigate supply chain disruption and ensure patient safety.

REGULATORY INTELLIGENCE
2020-12-02

AA PRODUCTS INC Recalls SYP Health Hand Sanitizer Due to Methanol Contamination and Subpotency

AA PRODUCTS INC initiated a Class II recall for SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70% due to manufacturing at a facility that produced subpotent and methanol-contaminated product. This event highlights critical CGMP deviations, necessitating enhanced due diligence for procurement and regulatory teams to ensure product safety and efficacy in the supply chain.

REGULATORY INTELLIGENCE
2020-12-02

Jubilant Cadista's clomiPRAMINE Recall: Implications for Psychiatric Drug Supply Chain Integrity

Jubilant Cadista Pharmaceuticals, Inc. faced a Class II FDA recall for 4,416 bottles of clomiPRAMINE Hydrochloride Capsules, 50 mg, due to failed tablet/capsule specifications. This voluntary, firm-initiated action, terminated in March 2022, underscores critical quality control vulnerabilities. Procurement directors must enhance supplier oversight and diversify sourcing for essential psychiatric medications to mitigate supply chain disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2020-12-02

EYWA PHARMA INC Levetiracetam Recall: Critical Foreign Tablet Contamination Exposes Supply Chain Vulnerabilities

EYWA PHARMA INC initiated a Class II recall (D-0109-2021) for 5,451 bottles of Levetiracetam Tablets, USP 500 mg, due to 1000 mg tablets found in 500 mg bottles. This critical quality control failure, originating from Indian manufacturer VKT Pharma, underscores significant supply chain risks for procurement and regulatory teams. The recall, initiated November 2020, was terminated October 2024, indicating resolution but demanding continued vigilance.

REGULATORY INTELLIGENCE
2020-12-02

FDA Terminates Fusion Health and Vitality LLC Recall for Unapproved Immune Boost Drug Claims

The FDA has terminated a Class II recall initiated by Fusion Health and Vitality LLC for its Immune Boost product, marketed with unapproved drug claims. This highlights critical regulatory compliance risks for companies operating in the dietary supplement space, underscoring the necessity for rigorous adherence to NDA/ANDA requirements to avoid market disruptions and reputational damage.

REGULATORY INTELLIGENCE
2020-11-25

Milbar Laboratories' Benzoyl Peroxide Wash Recalled Globally Due to GMP Deviations

Milbar Laboratories, Inc. initiated a Class II recall of 7,591 bottles of DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%) due to GMP deviations. This voluntary action, impacting global distribution, underscores critical supply chain and regulatory risks. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate similar disruptions and ensure product integrity.

REGULATORY INTELLIGENCE
2020-11-25

Preferred Pharmaceuticals Recalls Metformin HCl ER 500 mg Due to NDMA Contamination and CGMP Deviations

Preferred Pharmaceuticals, Inc. initiated a Class II recall of Metformin HCl Extended Release Tablets USP 500 mg due to N-Nitrosodimethylamine (NDMA) levels exceeding acceptable limits, stemming from CGMP deviations. This event, now terminated, underscores persistent nitrosamine risks in generic drug supply chains. Procurement and regulatory teams must enhance supplier scrutiny and impurity testing protocols.

REGULATORY INTELLIGENCE
2020-11-25

Grato Holdings Recalls Homeopathic Energy Catalyst Over Undeclared API and Formulation Errors

Grato Holdings, Inc. initiated a Class III recall of 399 bottles of its Homeopathic Energy Catalyst due to an undeclared active pharmaceutical ingredient (API) and incorrect formulation. This event, terminated in October 2022, underscores critical quality control failures. Procurement and regulatory teams must enhance supplier vigilance to prevent similar integrity breaches and ensure compliance across all product categories.

REGULATORY INTELLIGENCE
2020-11-25

Milbar Laboratories' Salicylic Acid Pads Recall Signals Persistent GMP Challenges for OTC Drug Manufacturers

Milbar Laboratories, Inc. initiated a Class II recall (D-0093-2021) for 2,638 jars of Willa Pore Perfector (Salicylic Acid 2%) pads due to GMP deviations. This event, now terminated, underscores critical quality control vulnerabilities in OTC drug manufacturing and global supply chains. Procurement and regulatory teams must scrutinize supplier compliance to mitigate similar disruptions and ensure product integrity.

REGULATORY INTELLIGENCE
2020-11-25

Albek De Mexico Faces Severe FDA Scrutiny Over Methanol Contamination in Hand Sanitizers

Albek De Mexico S.A. De C.V. initiated a nationwide Class II recall (D-0080-2021) for hand sanitizers due to critical CGMP deviations, including methanol contamination and sub-potent ethanol levels. This event highlights severe quality control failures at their San Juan Del Rio, Mexico facility, posing significant supply chain and regulatory risks for procurement directors and regulatory affairs heads sourcing from the region.

CLINICAL & PIPELINE
2020-11-19

Sandoz Inc. Secures Tentative FDA Approval for Generic ANDA 210481

Sandoz Inc. has received a Tentative Approval from the FDA for its Abbreviated New Drug Application (ANDA210481) on November 19, 2020. This signifies the generic drug meets all regulatory standards but cannot launch until reference product patents expire. This event signals future market competition and requires proactive monitoring by procurement and supply chain leaders for impending shifts in sourcing and pricing dynamics.

REGULATORY INTELLIGENCE
2020-11-18

H & H Remedies' Vapor Ointment Recall Highlights Enduring CGMP Compliance Risks for OTC Manufacturers

H & H Remedies, LLC's Class II recall of Vapor Ointment due to CGMP deviations underscores persistent quality control challenges in the OTC sector. Procurement and regulatory teams must enhance supplier qualification and audit programs to mitigate risks, ensuring product integrity and uninterrupted supply. This event, terminated in May 2024, serves as a critical reminder for vigilance.

REGULATORY INTELLIGENCE
2020-11-11

Marksans Pharma's Metformin Recall: NDMA Contamination Exposes Supply Chain Vulnerabilities for US Buyers

Marksans Pharma Limited initiated a Class II recall of Metformin Hydrochloride Extended-Release Tablets due to N-Nitrosodimethylamine (NDMA) impurity exceeding acceptable limits, stemming from CGMP deviations at its Goa, India facility. This nationwide recall, now terminated, underscores critical quality control challenges for procurement directors and regulatory affairs heads, demanding enhanced due diligence for pharmaceutical sourcing from India.

REGULATORY INTELLIGENCE
2020-11-04

Jarrow Formulas N-A-C Recall: FDA Class II Mislabelling Exposes Supply Chain Vulnerabilities

Jarrow Formulas Inc initiated a Class II voluntary recall of 533 units of N-A-C (N-Acetyl-L-Cysteine) 500 mg capsules due to mislabeling with N-A-C Sustain 600 mg tablets. This event, now terminated, underscores critical supply chain and regulatory risks for procurement and quality assurance teams, highlighting the need for robust labeling verification processes to maintain consumer trust and market access in the United States.

CLINICAL & PIPELINE
2020-11-02

SUN PHARM INDS LTD Secures FDA Tentative Approval for Generic ANDA210814

SUN PHARM INDS LTD has received Tentative Approval from the FDA for Abbreviated New Drug Application (ANDA) 210814 on November 2, 2020. This signifies the generic drug product meets all regulatory standards but cannot launch due to existing patent or exclusivity protections. This positions Sun Pharma for future market entry, impacting procurement and supply chain strategies for the undisclosed molecule.

CLINICAL & PIPELINE
2020-10-30

INSTAPILL Secures FDA Approval for Generic Loratadine 10mg Orally Disintegrating Tablets

INSTAPILL has received FDA approval for its generic Loratadine 10mg Orally Disintegrating Tablets (ANDA213294) on October 30, 2020. This standard review approval introduces a new over-the-counter option for allergy relief, intensifying competition in the antihistamine market and offering procurement and supply chain leaders an additional sourcing avenue for this widely used molecule.

REGULATORY INTELLIGENCE
2020-10-28

FDA Class I Recall: Acella Pharmaceuticals' NP Thyroid 15 Subpotency Raises Critical Supply Chain Concerns

Acella Pharmaceuticals, LLC faced an FDA Class I recall for subpotent NP Thyroid 15 tablets, containing less levothyroxine than labeled. This event, terminated in December 2022, underscores critical quality control and supply chain risks for procurement and regulatory teams in the US pharmaceutical market, demanding enhanced supplier due diligence.

REGULATORY INTELLIGENCE
2020-10-28

FDA Class III Recall: ANI Pharmaceuticals' Labeling Error on Mixed Amphetamine Salts Impacts Supply

ANI Pharmaceuticals, Inc. initiated a Class III recall (D-0047-2021) for 6,780 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules due to an incorrect 24-month expiration date instead of 18 months. This event highlights critical quality control lapses in labeling for a key CNS stimulant, impacting procurement and regulatory compliance for Amerigen Pharmaceuticals, Inc. and distributors nationwide.

REGULATORY INTELLIGENCE
2020-10-28

FDA Class II Recall: Genesis Partnership Company SA's Subpotent Hand Sanitizer Exposes CGMP Failures

Genesis Partnership Company SA faces an FDA Class II recall for 5,040 bottles of Genesis Hand Sanitizer Gel distributed nationwide in the U.S. The recall, initiated due to CGMP deviations linked to sub-potent ethanol levels, underscores critical quality control failures. This event highlights persistent compliance risks for procurement directors and regulatory affairs heads sourcing OTC products, necessitating enhanced supplier vigilance and robust testing protocols.

REGULATORY INTELLIGENCE
2020-10-21

Leadiant Biosciences CYSTARAN Recall: Subpotent Cysteamine HCl Exposes Ophthalmic Drug Quality Risks

Leadiant Biosciences, Inc. initiated a Class III recall for CYSTARAN (cysteamine ophthalmic solution) due to subpotent Cysteamine HCl. This event, impacting distribution in Pennsylvania and Italy, underscores critical quality control vulnerabilities in contract manufacturing. Procurement and regulatory teams must scrutinize supplier quality agreements and enhance oversight of active pharmaceutical ingredient (API) stability.

CLINICAL & PIPELINE
2020-10-20

SUN PHARM's Discontinued Generic Lansoprazole Receives Multiple Labeling Approvals: Implications for Regulatory Affairs and Supply Chain

SUN PHARM's Abbreviated New Drug Application (ANDA202637) for Lansoprazole 15mg capsules, though discontinued, recently received multiple labeling approvals. This event highlights ongoing regulatory obligations for inactive products and offers no new commercial opportunities. Decision-makers must prioritize compliance for historical portfolios and understand market dynamics for mature generics.

REGULATORY INTELLIGENCE
2020-10-14

FDA Terminates Class II Recall for Calvin Scott & Company's Diethylpropion Due to Repackaging cGMP Failures

Calvin Scott & Company, Inc. faced a Class II FDA recall for Diethylpropion 25 mg tablets, terminated April 22, 2024. The recall stemmed from critical cGMP deviations, specifically repackaging into pouches without supporting stability studies. This event underscores the imperative for robust quality agreements and rigorous oversight of third-party repackaging operations to mitigate supply chain and regulatory risks for procurement and regulatory affairs teams.

REGULATORY INTELLIGENCE
2020-10-07

4e Brands North America Hand Sanitizer Recall: CGMP Failures and Methanol Contamination Risks Highlight Supply Chain Vulnerabilities

4e Brands North America initiated a Class II recall of over 17 million Modesa Hand Sanitizer bottles due to manufacturing in a facility linked to methanol contamination, indicating severe CGMP deviations. This event underscores critical supply chain risks for US importers of OTC drugs, demanding heightened vigilance in supplier qualification and quality oversight to mitigate similar regulatory exposures.

REGULATORY INTELLIGENCE
2020-10-07

Teva Pharmaceuticals' Buprenorphine Transdermal System Recalled by FDA Over Stability Failures

Teva Pharmaceuticals USA initiated a Class II recall for its Buprenorphine Transdermal System 5 mcg/hour due to a critical failure in stability specifications, specifically a below-spec buprenorphine release rate. This nationwide recall, impacting 32,543 cartons manufactured by 3M Drug Delivery Systems, underscores the imperative for robust quality control and supplier oversight in pharmaceutical supply chains to prevent market disruptions and regulatory scrutiny.

REGULATORY INTELLIGENCE
2020-10-07

Arbor Pharmaceuticals' Nymalize Oral Solution Recalled Due to Subpotency: Critical Supply Chain Implications

Arbor Pharmaceuticals initiated a Class III recall of 1,846 cartons of Nymalize (nimodipine) oral solution due to subpotency, impacting nationwide U.S. distribution. This voluntary, firm-initiated action, terminated in February 2022, underscores critical quality control vulnerabilities in neurological drug manufacturing. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate supply chain disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2020-10-07

ChemLifeIntel Alert: Sun Pharma's RIOMET ER Metformin Recall Highlights Persistent NDMA Contamination Risks

SUN PHARMACEUTICAL INDUSTRIES INC initiated a Class II recall of RIOMET ER (metformin hydrochloride) due to N-nitrosodimethylamine (NDMA) impurity. This terminated recall, impacting 747 bottles, underscores critical cGMP deviations and ongoing nitrosamine risks. Procurement and regulatory teams must enhance supplier scrutiny and diversify sourcing to mitigate supply chain vulnerabilities.

CLINICAL & PIPELINE
2020-10-06

Acella Pharmaceuticals Secures Latest FDA Labeling Approval for Generic Phenytoin Sodium Injectable

Acella Pharmaceuticals, LLC has received FDA approval for a labeling supplement for its generic Phenytoin Sodium injectable (ANDA040573) on October 2, 2024. This update reinforces the product's regulatory compliance and continued market presence, offering stability for procurement and supply chain operations. The 50mg/mL anticonvulsant remains a critical component in epilepsy management, ensuring ongoing access to an established, therapeutically equivalent treatment.

REGULATORY INTELLIGENCE
2020-09-30

Perrigo's Albuterol Sulfate Recall: Over 7.7 Million Inhalers Pulled Due to Defective Delivery System

Perrigo Company PLC initiated a Class II recall of 7.7 million Albuterol Sulfate Inhalation Aerosol units due to a defective delivery system. This significant event, involving manufacturer Catalent Pharma Solutions, underscores critical supply chain vulnerabilities for essential respiratory medications. Procurement directors and supply chain VPs must reassess sourcing strategies and quality control for drug-device combination products to mitigate future disruptions.

REGULATORY INTELLIGENCE
2020-09-30

GRUPO YACANA MEXICO Recall: cGMP Deviations Prompted Class II Action on Yacana Alcohol Antiseptic

GRUPO YACANA MEXICO SAS DE CV faced a Class II recall (D-1590-2020) for its Yacana Alcohol Antiseptic 70% Topical Solution due to cGMP deviations. This action, initiated on August 18, 2020, involved 55,560 bottles distributed to Texas. The recall's termination on May 17, 2023, indicates remediation, but highlights persistent quality control risks in cross-border OTC pharmaceutical supply chains for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2020-09-30

AJR Trading LLC Recalls Bio AAA Hand Sanitizer Over Methanol Contamination and CGMP Deviations

AJR TRADING LLC initiated a Class II recall (D-1620-2020) of bio aaa Alcohol en Gel Antibacterial due to manufacturing in a facility where methanol was found in other product lots. This event underscores critical CGMP deviations and supply chain risks for US importers, demanding rigorous supplier qualification and product testing to protect consumer safety and business continuity.

REGULATORY INTELLIGENCE
2020-09-30

FDA Class II Recall of Repackaged Nature-Throid by Preferred Pharmaceuticals, Inc. Highlights CGMP Risks

Preferred Pharmaceuticals, Inc. faced a Class II FDA recall for repackaged Nature-Throid due to CGMP deviations, terminated in April 2024. This event underscores critical supply chain and regulatory risks for procurement, regulatory affairs, and supply chain VPs. Vigilant supplier qualification and continuous monitoring are essential to mitigate disruptions and ensure product quality, particularly with repackaging operations.

REGULATORY INTELLIGENCE
2020-09-23

Broncolin's HERBACIL Hand Sanitizer Class I Recall: Methanol Contamination Exposes Supply Chain Risks

Broncolin, S.A. de C.V. faced a Class I recall for its HERBACIL Hand Sanitizer due to methanol contamination and subpotent ethanol. This event, impacting 26,972 bottles distributed nationwide in the USA, highlights critical supply chain vulnerabilities and the imperative for rigorous quality control. Procurement and regulatory teams must prioritize supplier vetting and robust testing to mitigate severe public health and commercial risks.

REGULATORY INTELLIGENCE
2020-09-23

FDA Mandates Class I Recall for Maison Terre's Goldenseal Root Powder Organic Due to Microbial Contamination

Maison Terre, LLC faced a Class I FDA recall (D-1584-2020) for its Goldenseal Root Powder Organic due to contamination with dangerous microorganisms, including Enterobacter cloacae. This nationwide event, initiated August 2020, highlights critical quality control failures in non-sterile botanical products. Procurement directors must scrutinize supplier microbial testing and quality systems to mitigate severe public health risks and supply chain disruptions.

REGULATORY INTELLIGENCE
2020-09-23

RLC Labs' Thyroid USP Products Recalled Due to CGMP Deviations: Supply Chain and Regulatory Implications

RLC Labs Inc. initiated a Class II recall (D-1609-2020) for WP Thyroid and Westhroid Pure, 1 Grain (65 mg) Thyroid USP products, citing Current Good Manufacturing Practice (CGMP) deviations that led to subpotent conditions. This event, now terminated, underscores critical quality control vulnerabilities for procurement and regulatory teams managing essential hormone therapies, demanding robust supplier oversight.

REGULATORY INTELLIGENCE
2020-09-23

Real Clean Distribuciones SA de CV Hand Sanitizer Recall: Methanol Contamination Exposes Supply Chain Risks for US Importers

Real Clean Distribuciones SA de CV faced a Class II FDA recall for 917,280 bottles of 'scent theory KEEP CLEAN Moisturizing Hand Sanitizer' due to CGMP deviations, including methanol contamination and sub-potent ethanol. This event highlights critical supply chain vulnerabilities for US firms sourcing personal care products from Mexico, demanding enhanced due diligence and robust quality control protocols to mitigate severe regulatory and reputational risks.

REGULATORY INTELLIGENCE
2020-09-16

FDA Class II Recall: Open Book Extracts' Mislabeled Hand Sanitizer Exposes Critical Methanol Risk

Open Book Extracts initiated a Class II recall of Just Hand Sanitizer (Ethyl Alcohol 73%) due to mislabeling indicating methanol content. This event, impacting 2880 boxes distributed nationwide, underscores critical supply chain and regulatory risks. Decision-makers must enhance supplier vetting and labeling controls to mitigate similar hazards and safeguard consumer trust.

REGULATORY INTELLIGENCE
2020-09-16

Teva Pharmaceuticals Recalls 1.46 Million Cephalexin Bottles Over CGMP Deviations

Teva Pharmaceuticals USA, Inc. initiated a Class II voluntary recall (D-0013-2021) for 1,467,535 bottles of Cephalexin for Oral Suspension due to Current Good Manufacturing Practice (CGMP) deviations. This event, now terminated, highlights critical quality control risks where active ingredient levels were potentially outside specification limits. Procurement and regulatory teams must scrutinize supplier quality systems, even for generic products, to mitigate supply chain disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2020-09-09

FDA Class I Recall: SG24 LLC's SkinGuard 24 Hand Sanitizer Deemed Unapproved Drug Due to Methanol Content

SG24 LLC faced a Class I FDA recall for its SkinGuard 24 All-Day Hand Sanitizer, distributed nationwide from Bolingbroke, GA. The product, containing 0.56% methanol, was deemed an unapproved new drug, lacking required NDA/ANDA clearance. This event underscores critical regulatory compliance risks for chemical and life sciences firms, highlighting the imperative for rigorous ingredient verification and market authorization before product launch to avoid significant market disruptions and reputational damage.

REGULATORY INTELLIGENCE
2020-09-09

AAA Cosmetica Faces Severe Regulatory Scrutiny Following Class I Methanol Contamination Recall

AAA Cosmetica, SA de CV initiated a Class I recall of over 200,000 bottles of bio aaa Advance Hand Sanitizer due to methanol contamination. This severe regulatory event highlights critical quality control failures, posing significant health risks. Procurement and regulatory teams must reassess supplier vetting, especially for imported products, to mitigate similar supply chain vulnerabilities and ensure consumer safety.

REGULATORY INTELLIGENCE
2020-09-09

Laboratorios Jaloma Recalls 211,875 Hand Sanitizer Bottles Over cGMP Deviations: Supply Chain Implications

Laboratorios Jaloma S.A. de C.V. initiated a Class II recall of 211,875 bottles of Jaloma Antiseptic Hand Sanitizer due to cGMP deviations at its Guadalajara, Mexico facility. This event, terminated in August 2022, underscores persistent quality control challenges for OTC drug manufacturers. Procurement and regulatory teams must scrutinize supplier cGMP compliance, especially for critical products like sanitizers, to mitigate supply chain disruptions and ensure product integrity for end-users.

REGULATORY INTELLIGENCE
2020-09-09

FDA Class II Recall: Santa Cruz Biotechnology's Subpotent Hand Sanitizer Exposes Potency Control Gaps

Santa Cruz Biotechnology, Inc. faced a Class II FDA recall for 14,238 bottles of UltraCruz Hand Sanitizing Gel due to subpotency. This event, initiated August 7, 2020, and terminated June 14, 2021, highlights critical quality control vulnerabilities in pharmaceutical manufacturing. Procurement and regulatory teams must scrutinize supplier quality agreements and implement robust testing protocols to mitigate similar supply chain risks.

REGULATORY INTELLIGENCE
2020-09-02

Fresenius Kabi's Class I Dexmedetomidine HCl Recall Signals Critical Cross-Contamination Risks

Fresenius Kabi USA, LLC initiated a Class I recall of 25,100 bottles of Dexmedetomidine HCl due to trace lidocaine cross-contamination. This event, terminated in September 2022, underscores severe quality control vulnerabilities in sterile injectable manufacturing. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate supply chain disruption and patient safety risks from such critical drug product issues.

REGULATORY INTELLIGENCE
2020-09-02

FDA Class II Recall: Par Pharmaceutical's BusPIRone Hydrochloride Tablets Fail Impurity Specifications

Par Pharmaceutical Inc. initiated a Class II recall of 11,347 bottles of BusPIRone Hydrochloride Tablets, USP 7.5 mg, due to failed impurity specifications. This voluntary action, terminated in June 2021, underscores the critical need for robust quality control in pharmaceutical manufacturing. Procurement and regulatory teams must assess supplier quality systems to mitigate supply chain disruptions and compliance risks.

REGULATORY INTELLIGENCE
2020-09-02

BAYSHORE PHARMACEUTICALS' Metformin Hydrochloride Recall Highlights Persistent CGMP Risks in Global Supply Chains

BAYSHORE PHARMACEUTICALS initiated a nationwide Class II recall of Metformin Hydrochloride Extended-Release Tablets due to CGMP deviations. This event, involving product manufactured by Beximco Pharmaceuticals, LTD. in Bangladesh, underscores critical quality control challenges within global pharmaceutical supply chains. Procurement and regulatory teams must enhance supplier diligence to mitigate similar disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2020-09-02

FDA Class I Recall: SCA Pharmaceuticals' Heparin Sodium Contained Undeclared Benzyl Alcohol, Highlighting Critical Quality Control Gaps

SCA Pharmaceuticals initiated a Class I recall for 362 containers of Heparin Sodium 10,000 units/mL due to undeclared benzyl alcohol, mislabeled as parabens. This event, terminated in May 2021, underscores critical quality control and labeling deficiencies, posing significant risks for procurement and regulatory teams managing pharmaceutical supply chain integrity and patient safety.

REGULATORY INTELLIGENCE
2020-09-02

FDA Class II Recall: Resource Recovery & Trading LLC's Hand Sanitizer Pulled Due to cGMP Deviations

RESOURCE RECOVERY & TRADING LLC initiated a Class II recall for 115 bottles of HAND SANITIZER Non-sterile Solution 70% Topical Solution due to cGMP deviations. This event, impacting distribution in AL and GA, underscores critical supply chain and regulatory risks for procurement directors and regulatory affairs heads sourcing drug products, even from distributors.

REGULATORY INTELLIGENCE
2020-08-26

Ultra Seal Corporation's Pain Relief Recall Highlights Critical Aspirin Stability Failures and Supply Chain Risks

Ultra Seal Corporation initiated a Class III recall for 4.6 million packets of Pain Relief Maximum Strength tablets due to out-of-specification Salicylic Acid levels, a critical aspirin degradation product. This event underscores persistent quality control challenges in OTC drug manufacturing, demanding enhanced due diligence from procurement and regulatory teams managing complex supply chains and contract manufacturing relationships.

REGULATORY INTELLIGENCE
2020-08-26

Calvin Scott & Company's Phentermine Recall Highlights Critical CGMP Packaging Failures

Calvin Scott & Company, Inc. initiated a Class II recall for Phentermine 15mg capsules due to critical CGMP deviations. Light-sensitive drug products were repackaged into transparent pouches, compromising product integrity. This event, now terminated, underscores the necessity for robust packaging controls in pharmaceutical supply chains, impacting procurement and regulatory compliance for distributors in the United States.

CLINICAL & PIPELINE
2020-08-26

FDA Approves CARBAGLU Labeling Update for Recordati Rare Diseases' Orphan Drug

Recordati Rare Diseases secured FDA approval for a supplemental labeling update for its orphan drug, CARBAGLU (carglumic acid), on January 19, 2024. This standard review approval, following earlier efficacy expansions, signals refined prescribing information. For procurement, regulatory, and supply chain leaders, this reinforces CARBAGLU's market position, necessitating vigilance on updated compliance protocols and patient access strategies for this critical rare disease therapy.

REGULATORY INTELLIGENCE
2020-08-26

Ferring Pharmaceuticals Faces Class I Recall for Superpotent Desmopressin Acetate Nasal Spray

Ferring Pharmaceuticals Inc. initiated a Class I recall of 184,325 units of Desmopressin Acetate Nasal Spray due to superpotency. This event, terminated after three years, underscores critical quality control failures and significant patient safety risks. Procurement and regulatory teams must scrutinize supplier agreements and ensure robust quality management systems to mitigate similar supply chain vulnerabilities.

REGULATORY INTELLIGENCE
2020-08-26

CareFusion 213, LLC Initiates Class I Recall of ChloraPrep Applicators Due to Aspergillus Penicilloides Contamination

CareFusion 213, LLC, a Becton, Dickinson and Company subsidiary, executed a Class I recall of 2.8 million ChloraPrep applicators due to *Aspergillus Penicilloides* contamination. This global event, impacting 16 countries, underscores critical non-sterility risks in pre-operative skin preparations. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate similar supply chain disruptions.

REGULATORY INTELLIGENCE
2020-08-19

FDA Class II Recall: PAI Holdings' Subpotent Nystatin Oral Suspension Exposes Quality Control Gaps

PAI Holdings, LLC. dba Pharmaceutical Associates Inc initiated a Class II recall for subpotent Nystatin Oral Suspension. This event highlights critical quality control vulnerabilities, impacting procurement strategies and regulatory compliance for pharmaceutical buyers. Decision-makers must reassess supplier stability and diversify sourcing to mitigate future supply chain disruptions.

REGULATORY INTELLIGENCE
2020-08-19

Eosera, Inc. Faces FDA Class II Recall for Ear Itch MD Due to cGMP Deviations

Eosera, Inc. initiated a Class II recall for 43,424 bottles of Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) across the U.S. due to cGMP deviations. This event, terminated by the FDA in September 2021, underscores critical quality control vulnerabilities. Procurement and regulatory teams must scrutinize supplier compliance, especially for OTC drug products, to mitigate supply chain and reputational risks.

REGULATORY INTELLIGENCE
2020-08-19

Itech 361 LLC Hand Sanitizer Recall: Undeclared Methanol Exposes Critical Supply Chain Gaps

Itech 361 LLC initiated a Class I recall of 18,760 bottles of All Clean Hand Sanitizer due to undeclared methanol. This event, involving Mexican producer Eskbiochem SA de CV, highlights severe supply chain vulnerabilities and the critical need for enhanced due diligence for procurement directors and regulatory affairs heads to mitigate significant commercial and safety risks.

REGULATORY INTELLIGENCE
2020-08-19

Taro Pharmaceuticals Recalls Clobetasol Propionate Cream Over Content Uniformity Failure

Taro Pharmaceuticals U.S.A., Inc. recalled Clobetasol Propionate Cream USP, 0.05% due to content uniformity failure in the bulk lot. This Class III recall, initiated July 20, 2020, and terminated June 20, 2023, highlights critical quality control lapses at the Canadian manufacturing facility. Decision-makers must scrutinize supplier quality systems for topical formulations, ensuring robust blending and in-process controls to mitigate supply chain risks and safeguard patient safety.

CLINICAL & PIPELINE
2020-08-19

TERSERA's VARUBI (ROLAPITANT HYDROCHLORIDE) IV Emulsion: FDA Approval and Subsequent Discontinuation Impact

TERSERA's VARUBI (ROLAPITANT HYDROCHLORIDE) intravenous emulsion received FDA approval as a new dosage form (NDA208399) on October 25, 2017. Despite initial regulatory success, the product's marketing status is now discontinued. This event signals critical considerations for regulatory affairs, procurement, and business development teams regarding product lifecycle management and market dynamics for antiemetic therapies.

CLINICAL & PIPELINE
2020-08-18

FDA Approves APIL's ATELVIA (Risedronate Sodium) as New Delayed-Release Dosage Form

The FDA approved APIL's NDA022560 for ATELVIA (Risedronate Sodium) as a Type 3 new delayed-release dosage form on October 8, 2010. This strategic approval for the 35MG oral tablet differentiates APIL's product in the market, necessitating ongoing regulatory and supply chain vigilance for this long-lifecycle asset, with updates extending to 2026.

REGULATORY INTELLIGENCE
2020-08-12

MICHIGAN HERBAL REMEDIES CBD Oil Recalled Nationwide Due to Class I Lead Contamination

MICHIGAN HERBAL REMEDIES initiated a Class I recall of its BC Hemp Co. Full Spectrum Hemp Extract CBD Oil due to elevated, undeclared lead levels. This nationwide distribution event, D-1457-2020, underscores critical supply chain vulnerabilities in botanical extracts. Procurement, regulatory, and supply chain leaders must implement stringent heavy metal testing and robust supplier qualification to mitigate severe health risks and protect brand integrity in the evolving CBD market.

REGULATORY INTELLIGENCE
2020-08-12

Summitt Labs' KORE ORGANIC CBD Oil Recalled Nationwide Due to Class I Lead Contamination

Summitt Labs initiated a Class I recall of 236 bottles of KORE ORGANIC CBD Oil Watermelon 15mg nationwide due to elevated lead levels. This event underscores critical chemical contamination risks in nutraceutical supply chains, demanding heightened vigilance from procurement and regulatory teams. The recall, D-1489-2020, highlights the imperative for robust quality control.

REGULATORY INTELLIGENCE
2020-08-12

Vilvet Pharmaceuticals' VILEVEV MB Recall Highlights Persistent cGMP Compliance Risks for Urinary Antiseptics

Vilvet Pharmaceuticals Inc. initiated a Class II nationwide recall of 1,716 bottles of VILEVEV MB Urinary Antispetic due to cGMP deviations. This event, terminated in January 2022, underscores persistent quality control challenges in pharmaceutical manufacturing. Procurement and regulatory teams must enhance supplier due diligence and quality oversight to mitigate supply chain disruptions and ensure patient safety from similar compliance risks.

REGULATORY INTELLIGENCE
2020-08-05

UVT INC's Saniderm Hand Sanitizer Recall: Undeclared Methanol Exposes Critical Supply Chain Vulnerabilities

UVT INC initiated a Class I recall of 38,016 bottles of Saniderm ADVANCED HAND SANITIZER due to undeclared methanol, produced by Eskbiochem SA de CV. This event underscores severe risks in global supply chains for OTC products, demanding enhanced due diligence and robust quality control from procurement and regulatory teams to mitigate health hazards and commercial liabilities.

CLINICAL & PIPELINE
2020-08-05

Strides Pharma Intl Secures FDA Approval for Generic Sevelamer Carbonate 800mg Tablets

Strides Pharma Intl secured FDA approval for its Abbreviated New Drug Application (ANDA201069) for Sevelamer Carbonate 800mg tablets on August 5, 2020. This approval positions Strides Pharma Intl to enter the market for this critical molecule, particularly significant given the reference product's discontinued status. Procurement and supply chain leaders should evaluate Strides Pharma Intl as a new, viable source, enhancing supply diversification and cost management strategies.

REGULATORY INTELLIGENCE
2020-08-05

Sun Pharma's Clonazepam Recall Signals Persistent Cross-Contamination Risks in US Pharmaceutical Supply Chains

Sun Pharmaceutical Industries Inc. initiated a Class III recall of Clonazepam Orally Disintegrating Tablets due to clozapine cross-contamination, impacting 3,516 bottles nationwide. This event, now terminated, highlights critical manufacturing control vulnerabilities. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate similar risks and ensure patient safety and supply chain integrity.

REGULATORY INTELLIGENCE
2020-08-05

Allergan PLC Initiates Nationwide Recall of Skin Medica Acne System Due to Subpotency

Allergan PLC voluntarily recalled 8,555 Skin Medica Acne System kits nationwide due to subpotent Salicylic Acid and Benzoyl Peroxide. This Class III recall, initiated July 6, 2020, and terminated February 28, 2024, highlights critical quality control failures. Procurement directors must assess supplier stability data, while regulatory affairs and supply chain VPs should review internal quality assurance protocols to mitigate similar risks.

REGULATORY INTELLIGENCE
2020-08-05

FDA Terminates Recall of WORLD EVENT PROMOTIONS' Subpotent Handese Hand Sanitizer: Key Lessons for OTC Quality Control

The FDA has terminated the Class II recall of WORLD EVENT PROMOTIONS, LLC's Handese Advanced Instant Hand Sanitizer. This action, initiated due to subpotency of Ethyl Alcohol 70% and high pH levels, highlights critical quality control failures in OTC drug manufacturing. Procurement and regulatory teams must reinforce supplier qualification and robust analytical testing protocols to mitigate similar supply chain risks.

REGULATORY INTELLIGENCE
2020-08-05

MasterPharm LLC's Formula 82M Recall Highlights Critical Processing Control Lapses

MasterPharm LLC faced a Class II recall for 543 units of Formula 82M due to a lack of processing controls, impacting nationwide U.S. distribution. This event underscores the critical need for robust quality assurance in pharmaceutical manufacturing, prompting procurement and regulatory teams to re-evaluate supplier vetting and compliance oversight to mitigate supply chain risks.

REGULATORY INTELLIGENCE
2020-08-05

Lupin Pharmaceuticals Initiates Class II Recall for Lisinopril Tablets Due to Dose Mix-Up, Impacting US Supply Chains

Lupin Pharmaceuticals Inc. has voluntarily recalled 11,688 bottles of Lisinopril Tablets USP, 10 mg, due to 20 mg tablets found in 10 mg bottles. This Class II recall, initiated July 17, 2020, and terminated August 26, 2021, highlights critical quality control vulnerabilities at the manufacturing site, Lupin Limited in Nagpur, India. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate similar supply disruptions and patient safety risks.

CLINICAL & PIPELINE
2020-07-31

Amneal Pharmaceuticals' Tigecycline NDA: Supply Chain Diversification Amidst Compliance Scrutiny

Amneal Pharmaceuticals secured FDA approval for TIGECYCLINE (NDA211158) as a new manufacturer in August 2018, diversifying the supply of this critical intravenous antibacterial. While a recent labeling update in March 2025 confirms ongoing regulatory compliance, procurement and supply chain leaders must critically assess Amneal's documented history of high-severity CGMP risks and Metformin recalls, necessitating enhanced due diligence for TIGECYCLINE sourcing to mitigate potential supply disruptions.

REGULATORY INTELLIGENCE
2020-07-29

Lupin Pharmaceuticals' Cefdinir Recall Highlights Critical Superpotency Risks and Supply Chain Vulnerabilities

Lupin Pharmaceuticals Inc. initiated a Class II recall of Cefdinir for Oral Suspension due to superpotency, stemming from out-of-specification assay results. This event, impacting 35,928 bottles nationwide, underscores persistent quality control challenges within the global pharmaceutical supply chain. Procurement and regulatory teams must scrutinize Lupin's manufacturing oversight and diversify sourcing strategies to mitigate future disruptions and ensure product integrity.

REGULATORY INTELLIGENCE
2020-07-29

FDA Class III Recall of Fresenius Kabi's Famotidine Injection Highlights Critical Cold Chain Gaps

Fresenius Kabi USA, LLC's Famotidine Injection faced a Class III FDA recall due to temperature abuse during distribution, impacting a single lot. This event underscores the critical need for robust cold chain management and rigorous oversight of logistics partners. Procurement and supply chain leaders must enhance audit protocols to safeguard product integrity and patient safety.

REGULATORY INTELLIGENCE
2020-07-22

Granules Pharmaceuticals' Metformin ER Recall: NDMA Contamination Exposes Global Supply Chain Risks

Granules Pharmaceuticals Inc. initiated a nationwide Class II recall (D-1386-2020) for Metformin Hydrochloride Extended-Release Tablets, 750 mg, due to N-Nitrosodimethylamine (NDMA) impurity levels exceeding acceptable limits. This voluntary action, stemming from FDA analysis detecting CGMP deviations, impacts 476,073 bottles of 100-count and 2,100 bottles of 500-count, manufactured by Granules India Limited. This event underscores persistent quality control challenges in the global Metformin supply chain.

REGULATORY INTELLIGENCE
2020-07-22

Akorn's Proparacaine Hydrochloride Recall: Critical Lessons from Chemical Contamination and Cleaning Failures

Akorn, Inc. faced a Class III recall for Proparacaine Hydrochloride Ophthalmic Solution due to chemical contamination from out-of-specification equipment cleaning. This event, originating from their Lake Forest, IL facility, underscores critical vulnerabilities in sterile manufacturing quality control. Decision-makers must scrutinize supplier cleaning validation and ensure robust supply chain resilience for ophthalmic products.

REGULATORY INTELLIGENCE
2020-07-22

Fresenius Kabi Fosaprepitant Recall: Excipient Labeling Error Impacts US Supply Chain

Fresenius Kabi USA, LLC initiated a Class III recall for 63,067 vials of Fosaprepitant for Injection due to an excipient labeling error. The carton incorrectly stated edetate disodium quantity, highlighting critical regulatory compliance and supply chain oversight needs. This event underscores the imperative for robust quality control and accurate product information for pharmaceutical procurement and regulatory teams.

REGULATORY INTELLIGENCE
2020-07-22

Lupin Pharmaceuticals Metformin Recall: NDMA Contamination Exposes CGMP Risks

Lupin Pharmaceuticals initiated a Class II recall for Metformin Hydrochloride Extended-release Tablets due to N-Nitrosodimethylamine (NDMA) impurity exceeding acceptable levels. This voluntary action, stemming from CGMP deviations at its Goa, India, facility, highlights critical supply chain vulnerabilities for procurement and regulatory teams managing generic drug portfolios in the United States.

REGULATORY INTELLIGENCE
2020-07-15

Biogen's Tecfidera Recall: Critical cGMP Deviations Impact US Pharmaceutical Supply Chain

Biogen Inc. initiated a Class III recall of 3,922 bottles of Tecfidera (dimethyl fumarate) due to cGMP deviations, specifically distributing a lot rejected during in-process control. This event, now terminated, highlights critical quality control vulnerabilities for pharmaceutical procurement and supply chain leaders, emphasizing the imperative for stringent supplier oversight and robust internal quality assurance protocols.

REGULATORY INTELLIGENCE
2020-07-15

Somerset Therapeutics' Brimonidine Tartrate Recall Highlights Ophthalmic Product Stability Risks

Somerset Therapeutics, LLC initiated a Class III recall of 48,852 bottles of Brimonidine Tartrate Ophthalmic Solution 0.2% due to label leaching impacting product stability. This event, now terminated, underscores critical packaging material compatibility challenges and the imperative for robust quality control in global pharmaceutical supply chains, particularly for generic ophthalmic drugs manufactured in India for the US market.

REGULATORY INTELLIGENCE
2020-07-08

FDA Class II Recall: The Harvard Drug Group's Metformin Hydrochloride Impurity Highlights Persistent NDMA Risks

The Harvard Drug Group initiated a Class II recall (D-1360-2020) for Metformin Hydrochloride Extended-Release Tablets, 500 mg, due to potential Nitrosodimethylamine (NDMA) impurity exceeding established levels. This event, impacting 1,906 cartons distributed nationwide, underscores persistent CGMP risks in the pharmaceutical supply chain. Decision-makers must reinforce supplier qualification and enhance analytical testing protocols for active pharmaceutical ingredients.

REGULATORY INTELLIGENCE
2020-07-08

Beaming White Llc's Koala Hand Sanitizer Recall: Subpotent Ethanol and Undeclared Isopropyl Alcohol Expose Supply Chain Risks

Beaming White Llc initiated a Class II recall for its Koala Hand Sanitizer due to subpotent ethyl alcohol and undeclared isopropyl alcohol. This event, terminated in March 2024, highlights critical quality control failures and ingredient transparency issues in OTC drug manufacturing. Procurement and regulatory teams must enhance supplier vigilance to mitigate similar supply chain vulnerabilities and ensure product efficacy.

CLINICAL & PIPELINE
2020-07-02

Teva Pharmaceuticals Secures Tentative FDA Approval for Generic Apixaban (ANDA210142)

Teva Pharmaceuticals USA Inc. has received Tentative Approval from the FDA for its generic APIXABAN 2.5mg oral tablets (ANDA210142) on August 21, 2020. This confirms bioequivalence and manufacturing readiness, positioning Teva for market entry once patent and exclusivity barriers expire. Decision-makers should prepare for future supply chain diversification and increased market competition in the anticoagulant sector, leveraging this regulatory milestone for strategic planning.

REGULATORY INTELLIGENCE
2020-07-01

Teva's Metformin Recall Highlights Persistent NDMA Contamination and CGMP Risks

Teva Pharmaceuticals USA initiated a Class II recall of Metformin Hydrochloride Extended-Release Tablets due to N-Nitrosodimethylamine (NDMA) impurity above acceptable levels, stemming from CGMP deviations. This event, now terminated, underscores critical supply chain and regulatory risks for procurement and quality assurance teams, demanding rigorous oversight of contract manufacturers like Watson Pharma Private Limited.

REGULATORY INTELLIGENCE
2020-07-01

Aurobindo Pharma's Clozapine Recall: Foreign Tablet Contamination Exposes Critical Supply Chain Vulnerabilities

Aurobindo Pharma USA Inc. initiated a Class II recall for 1,440 bottles of Clozapine Tablets USP 100mg due to foreign tablet contamination. This event, now terminated, highlights critical quality control vulnerabilities in pharmaceutical manufacturing and distribution. Procurement and regulatory teams must scrutinize supplier quality systems, particularly for generic antipsychotics like Clozapine, to safeguard patient safety and ensure supply chain integrity against similar deviations.

REGULATORY INTELLIGENCE
2020-07-01

FDA Class III Recall: Rising Pharmaceuticals' Timolol Maleate Ophthalmic Solution Labeling Error Exposes Supply Chain Vulnerabilities

Rising Pharmaceuticals, Inc. initiated a Class III recall for Timolol Maleate Ophthalmic Solution due to a critical labeling mix-up. A 0.25% strength bottle was incorrectly packaged in a 0.5% strength carton. This event, now terminated, underscores the imperative for robust quality control in pharmaceutical supply chains, particularly for products manufactured by FDC Limited in India and distributed nationwide across the U.S.

REGULATORY INTELLIGENCE
2020-07-01

Crown Laboratories' Nystatin Cream Recall: Subpotency Exposes Stability Testing Gaps in Topical Antifungal Supply

Crown Laboratories initiated a Class II recall for 62,274 tubes of Nystatin Cream due to subpotency, impacting nationwide distribution. This event underscores critical vulnerabilities in stability testing and quality control for topical antifungal products, demanding immediate review of supplier qualification and internal quality assurance protocols by procurement and regulatory teams.

REGULATORY INTELLIGENCE
2020-07-01

Amneal Pharmaceuticals Metformin Recall: NDMA Contamination Exposes Persistent CGMP Risks

Amneal Pharmaceuticals of New York, LLC initiated a nationwide Class II recall of Metformin Hydrochloride Extended-Release Tablets due to N-Nitrosodimethylamine (NDMA) impurity exceeding acceptable levels. This event underscores persistent CGMP deviations and systemic nitrosamine contamination risks across the pharmaceutical supply chain, demanding immediate attention from procurement and regulatory leaders to ensure product safety and supply continuity.

REGULATORY INTELLIGENCE
2020-07-01

Lupin Pharmaceuticals' Metformin Recall: NDMA Contamination Exposes CGMP Deviations and Supply Chain Risks

Lupin Pharmaceuticals Inc. executed a Class II recall of Metformin Hydrochloride Extended-release Tablets due to N-Nitrosodimethylamine (NDMA) impurity exceeding acceptable limits, stemming from CGMP deviations at its Goa, India manufacturing site. This event underscores critical quality control vulnerabilities within global pharmaceutical supply chains, necessitating immediate action from procurement and regulatory affairs to mitigate patient safety risks and ensure supply continuity for this essential diabetes medication.

REGULATORY INTELLIGENCE
2020-07-01

Amneal Pharmaceuticals Recalls Metformin Due to NDMA Contamination, Highlighting Systemic CGMP Risks

Amneal Pharmaceuticals of New York, LLC initiated a Class II recall (D-1348-2020) for Metformin Hydrochloride Extended-Release Tablets, 750 mg, due to N-Nitrosodimethylamine (NDMA) impurity exceeding acceptable levels, identified by FDA analysis. This event underscores persistent Current Good Manufacturing Practice (CGMP) deviations within the pharmaceutical supply chain, demanding immediate attention from procurement and regulatory leaders.

REGULATORY INTELLIGENCE
2020-07-01

FDA Class II Recall: BIOTA Biosciences' Sterile CBD + Curcumin Vials Flagged for Sterility and Unapproved Drug Status

BIOTA Biosciences LLC initiated a Class II recall for its Sterile Cannabidiol (CBD) + Curcumin 50mg/mL vials due to sterility assurance failures and marketing an unapproved drug. This event, impacting US and New Zealand markets, underscores critical regulatory and quality control risks for procurement and regulatory teams. Companies must scrutinize suppliers of novel compounds like CBD for robust FDA compliance and manufacturing integrity to mitigate supply chain disruptions.

REGULATORY INTELLIGENCE
2020-06-24

Aurobindo Pharma USA Recalls Olanzapine Tablets Over Impurity and Degradation Failures

Aurobindo Pharma USA Inc. initiated a Class III nationwide recall (D-1315-2020) for 7,547 bottles of Olanzapine Tablets, USP 7.5 mg, manufactured by Aurolife Pharma LLC. The action, terminated January 10, 2023, stemmed from failed impurities/degradation specifications. This highlights critical quality control vulnerabilities for procurement and regulatory teams, necessitating rigorous supplier oversight, especially for generic pharmaceuticals distributed through partners like Prasco Laboratories.

REGULATORY INTELLIGENCE
2020-06-24

FDA Class II Recall: SCA Pharmaceuticals' Heparin Sodium Subpotency Exposes Critical Quality Control Failures

SCA Pharmaceuticals initiated a Class II recall of Heparin Sodium 5,000 units/mL due to subpotency, impacting hospitals in PA and CA. This event, coupled with a prior Class I recall for Heparin Sodium, signals persistent quality control deficiencies. Procurement and regulatory teams must scrutinize SCA's manufacturing processes and ensure robust supplier qualification to mitigate supply chain risks.

REGULATORY INTELLIGENCE
2020-06-24

Haleon US Holdings LLC Faces FDA Scrutiny Over Gaviscon Labeling Non-Compliance, Prompting Nationwide Recall

Haleon US Holdings LLC initiated a nationwide Class II recall (D-1323-2020) for 151,344 bottles of Gaviscon Regular Strength Liquid Antacid Cool Mint due to missing Magnesium safety warnings. This FDA-classified regulatory compliance breach underscores critical risks for procurement and regulatory teams in OTC drug labeling, demanding enhanced vigilance in quality control and supply chain oversight to prevent market disruption and reputational damage.

REGULATORY INTELLIGENCE
2020-06-17

Fresenius Kabi USA Recalls 5.3 Million Vials of Ketorolac Tromethamine Due to Particulate Matter

Fresenius Kabi USA, LLC initiated a Class I recall for 5,314,400 vials of Ketorolac Tromethamine Injection, USP, 30 mg per mL, due to particulate matter. This significant event, active from April 2020 to October 2023, posed substantial supply chain risks and patient safety concerns across the USA and Puerto Rico, demanding immediate action from procurement and regulatory teams to ensure continuity of critical injectable pain management therapies.

REGULATORY INTELLIGENCE
2020-06-17

Unichem Pharmaceuticals USA Inc. Initiates Nationwide Recall of Clonidine Hydrochloride Tablets Due to Benzophenone Contamination

Unichem Pharmaceuticals USA Inc. has completed a Class III recall of 190,992 bottles of Clonidine Hydrochloride Tablets nationwide. The recall, initiated voluntarily, addressed potential benzophenone migration from product containers, failing impurity specifications. This event underscores critical risks in pharmaceutical packaging integrity and the necessity for rigorous supplier and material qualification processes for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2020-06-10

AvKARE Lamotrigine Recall: Foreign Substance Contamination Exposes Supply Chain Vulnerabilities

AvKARE's Class III recall of Lamotrigine Tablets, USP, 150 mg, due to desiccant granule contamination, highlights critical quality control lapses. This event, coupled with AvKARE's prior recalls, signals heightened supply chain risks. Procurement and regulatory teams must intensify due diligence for products sourced from or distributed by AvKARE to mitigate potential disruptions.

REGULATORY INTELLIGENCE
2020-06-10

TRIOVA PHARMACEUTICALS LLC Estriol Recall: Organic Impurity Failures Expose API Quality Control Gaps

TRIOVA PHARMACEUTICALS LLC initiated a Class II nationwide recall of Estriol USP Micronized 5 G due to failed organic impurities and degradation specifications. This event, now terminated, highlights critical quality control vulnerabilities in API supply chains. Procurement and regulatory teams must reinforce supplier qualification and analytical testing protocols to mitigate risks from out-of-specification raw materials, safeguarding product integrity and patient safety.

REGULATORY INTELLIGENCE
2020-06-10

Acella Pharmaceuticals' NP Thyroid 60 Class I Recall: Superpotency Risks and Supply Chain Implications

Acella Pharmaceuticals, LLC initiated a Class I recall of 29,304 bottles of NP Thyroid 60 (Levothyroxine, Liothyronine) due to superpotency, posing significant patient risk and supply chain disruption. This event, terminated in January 2022, underscores critical quality control vulnerabilities for manufacturers of thyroid hormone replacement therapies, demanding rigorous supplier vetting and robust analytical testing protocols from procurement and regulatory teams.

REGULATORY INTELLIGENCE
2020-06-10

Teva Pharmaceuticals Recalls Mixed Amphetamine Salts Tablets Over Mixed Strengths

Teva Pharmaceuticals USA, Inc. initiated a Class II recall for 33,280 bottles of its Mixed Amphetamine Salts Tablets due to mixed strengths within bottles. This voluntary action, terminated in May 2021, highlights critical quality control vulnerabilities impacting product efficacy and patient safety. Procurement and regulatory teams must scrutinize supplier quality systems for similar high-risk products.

REGULATORY INTELLIGENCE
2020-06-10

Teva Pharmaceuticals USA Recalls Mixed Amphetamine Salts Tablets Over Strength Discrepancies

Teva Pharmaceuticals USA initiated a Class II recall of 41,348 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets due to mixed strengths. This voluntary action, terminated in May 2021, highlights critical quality control vulnerabilities, impacting patient safety and supply chain stability for this essential ADHD medication across the US and Puerto Rico.

REGULATORY INTELLIGENCE
2020-06-03

West-Ward Columbus Inc Initiates Class II Recall of Doxycycline Hyclate Tablets Due to Dissolution Failure

West-Ward Columbus Inc initiated a Class II recall (D-1274-2020) for 68,376 bottles of Doxycycline Hyclate Tablets due to failed dissolution specifications at shelf-life end. This event, now terminated, highlights critical quality control vulnerabilities for generic antibiotic suppliers. Procurement and supply chain leaders must scrutinize quality assurance protocols and diversify sourcing for essential medicines like Doxycycline Hyclate to mitigate disruption risks and ensure patient access.

REGULATORY INTELLIGENCE
2020-06-03

FDA Recall: Wuhan Bingbing Pharmaceutical's CGMP Failures Impact US Mencaine Patch Supply

Wuhan Bingbing Pharmaceutical Co., Ltd. initiated a Class II recall of Mencaine Patches due to critical CGMP deviations, specifically lost manufacturing records and retain samples. This impacts 1,800 pouches distributed nationwide in the USA, manufactured for Terrain Pharmaceuticals. This event underscores persistent global supply chain vulnerabilities and demands heightened due diligence from procurement and regulatory teams.

CLINICAL & PIPELINE
2020-05-28

Rubicon Research's Generic Buspirone Hydrochloride Approval: A Deep Dive into Early Market Entry and Supply Chain Dynamics

Rubicon Research secured FDA approval for its Abbreviated New Drug Application (ANDA075521) for generic BUSPIRONE HYDROCHLORIDE tablets on April 5, 2002. This early market entry for the anxiolytic drug provided significant commercial advantage. The approval, covering multiple strengths, highlights strategic generic positioning and ongoing regulatory compliance, with Advagen Pharma Ltd. identified as a key manufacturing partner in the supply chain.

REGULATORY INTELLIGENCE
2020-05-27

InvaGen Pharmaceuticals' Gabapentin Recall: Impurity Failure Exposes Generic Drug Stability Risks

InvaGen Pharmaceuticals initiated a Class III recall of Gabapentin Tablets USP, 600 mg, due to Impurity A failure during stability testing. This event, affecting 2,202 bottles distributed nationwide, underscores critical quality control vulnerabilities in generic drug manufacturing. Procurement directors must reassess supplier stability protocols, while regulatory affairs must ensure robust impurity monitoring to safeguard product integrity and patient safety.

REGULATORY INTELLIGENCE
2020-05-27

ICU Medical Inc. Recalls 93,648 Units of Lactated Ringer's Injection Due to Iron Oxide Particulate Matter

ICU Medical Inc. initiated a Class I recall for 93,648 units of LACTATED RINGER'S Injection, USP 1000 mL, manufactured by Hospira, Inc., due to confirmed iron oxide particulate matter. This event, now terminated, underscores critical supply chain vulnerabilities for essential injectables. Procurement and regulatory teams must scrutinize quality agreements and diversify sourcing to mitigate patient safety risks and ensure continuity of care amidst persistent industry-wide quality control challenges.

REGULATORY INTELLIGENCE
2020-05-27

West-Ward Columbus Inc's Ethacrynic Acid Recall Signals Persistent Impurity Control Challenges for US Supply

West-Ward Columbus Inc initiated a Class III recall of Ethacrynic Acid Tablets due to out-of-specification impurities and degradants. This event, impacting 3,336 bottles distributed nationwide, highlights critical quality control vulnerabilities. For procurement and regulatory teams, it signals potential systemic issues, reinforcing the need for stringent supplier oversight and robust risk mitigation strategies given the company's prior compliance history.

REGULATORY INTELLIGENCE
2020-05-20

Haleon US Holdings LLC Initiates Class III Recall for ChapStick Total Hydration Due to Packaging Separation

Haleon US Holdings LLC, formerly Glaxosmithkline Consumer Healthcare Holdings, initiated a Class III recall (D-1267-2020) for ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry due to secondary packaging separation. This voluntary action, affecting 288 packages nationwide, highlights the critical need for robust quality control in packaging processes, impacting supply chain integrity and brand perception for OTC drug products.

CLINICAL & PIPELINE
2020-05-20

MSN Laboratories Secures FDA Approval for Generic Oseltamivir Phosphate, Intensifying Market Competition

MSN Laboratories Private Limited received FDA approval for its Oseltamivir Phosphate generic capsules (ANDA212544) on May 20, 2020. This significant development introduces a new bioequivalent option in 30mg, 45mg, and 75mg strengths, enhancing supply chain diversity and competitive pricing for procurement directors. As an Indian API manufacturer, MSN's entry reinforces global generic supply dynamics.

CLINICAL & PIPELINE
2020-05-20

Cipla Secures FDA Approval for Generic Dihydroergotamine Mesylate Nasal Spray (ANDA212907)

Cipla USA Inc. received FDA approval for its generic DIHYDROERGOTAMINE MESYLATE NASAL spray (ANDA212907) on May 20, 2020, with a labeling update on September 12, 2023. This "AB" rated therapeutic equivalent product offers procurement directors a cost-effective alternative, intensifying competition in the nasal spray market. Supply chain VPs should anticipate pricing pressure, while business development executives can leverage increased market access for this critical medication.

CLINICAL & PIPELINE
2020-05-18

Alembic Pharmaceuticals Secures FDA Approval for Generic Clobetasol Propionate 0.05% Topical Shampoo

Alembic Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA213290) for Clobetasol Propionate 0.05% Topical Shampoo. This generic approval, granted on May 18, 2020, introduces a bioequivalent alternative into the market, signaling increased competition and potential cost efficiencies for procurement directors. Supply chain VPs should assess sourcing diversification, while regulatory affairs heads must monitor market shifts.

CLINICAL & PIPELINE
2020-05-14

Aurobindo Pharma Secures FDA Approval for Generic Albuterol Sulfate Oral Tablets, Intensifying Market Competition

Aurobindo Pharma Ltd. has received FDA approval for generic Albuterol Sulfate oral tablets (ANDA213657) on May 14, 2020. This expands generic options for respiratory care, driving cost competition. Procurement and supply chain leaders must assess Aurobindo's manufacturing stability, given its high-risk profile and history of recalls, to ensure reliable supply.

REGULATORY INTELLIGENCE
2020-05-13

Sandoz Infuvite Pediatric Recall: Sub-Optimal Vial Crimping Exposes Critical Container Integrity Risks

Sandoz Inc. initiated a Class II recall for 17,500 units of INFUVITE PEDIATRIC (Multiple Vitamins Injection) due to sub-optimal vial crimping. This FDA-terminated recall, impacting nationwide U.S. distribution, underscores the critical importance of container closure integrity in sterile pharmaceutical products. Procurement and regulatory teams must scrutinize packaging supplier quality and manufacturing process controls to mitigate similar supply chain disruptions.

CLINICAL & PIPELINE
2020-05-11

Unichem Pharmaceuticals Secures Multiple FDA Approvals for Generic Tramadol Hydrochloride, Bolstering Pain Management Supply

Unichem Pharmaceuticals (USA), Inc. has received multiple FDA approvals for its generic Tramadol Hydrochloride 50mg tablets, including the original ANDA approval in 2019 and numerous subsequent labeling and REMS updates through 2026. This reinforces the availability of a critical pain medication, impacting procurement strategies, regulatory compliance, and supply chain resilience for stakeholders in the global chemical and life sciences industry.

REGULATORY INTELLIGENCE
2020-05-06

B. Braun Medical Inc. Faces Class I Recall for Ceftazidime/Dextrose Due to High Molecular Weight Polymers

B. Braun Medical Inc. initiated a Class I recall for its Ceftazidime for Injection USP and Dextrose for Injection USP due to out-of-specification results for High Molecular Weight Polymers. This voluntary action, impacting 22,488 units nationwide, underscores critical quality control vulnerabilities in sterile injectables. Procurement and regulatory teams must scrutinize supplier stability data to mitigate patient safety and supply chain risks.

REGULATORY INTELLIGENCE
2020-05-06

Amneal Pharmaceuticals Recalls Nizatidine Oral Solution Over NDMA Contamination and CGMP Deviations

Amneal Pharmaceuticals of New York, LLC initiated a Class II recall of Nizatidine Oral Solution due to potential N-Nitrosodimethylamine (NDMA) levels exceeding FDA limits and Current Good Manufacturing Practice (CGMP) deviations. This nationwide recall, impacting 11,258 bottles, underscores critical quality control failures and necessitates immediate review of H2 antagonist supply chains for procurement and regulatory teams.

CLINICAL & PIPELINE
2020-05-05

ScieGen Pharms Strengthens Generic Metformin Hydrochloride Market with Diverse Tablet Portfolio

ScieGen Pharms has secured multiple approvals for its Abbreviated New Drug Application (ANDA203769) for generic Metformin Hydrochloride tablets, including original market entry in 2013 and subsequent manufacturing and labeling updates through 2020. This reinforces the competitive landscape for this essential oral antidiabetic, offering procurement directors diversified supply options across various strengths. Regulatory affairs teams should note the ongoing lifecycle management demonstrated by these approvals.

REGULATORY INTELLIGENCE
2020-04-29

Lupin Pharmaceuticals Initiates Class II Recall for Subpotent Cefixime Oral Suspension: Critical Quality Failure Impacts US Market

Lupin Pharmaceuticals Inc. initiated a Class II voluntary recall for 4,518 bottles of Cefixime for Oral Suspension USP due to subpotency. This event, stemming from a stability study failure, highlights critical quality control vulnerabilities. Procurement, regulatory, and supply chain leaders must reassess supplier qualification and risk mitigation strategies to prevent similar disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2020-04-29

Yusef Manufacturing Laboratories Recalls SPF Lip Moisturizers Due to Superpotent Oxybenzone Levels

Yusef Manufacturing Laboratories, LLC faced an FDA Class II recall for SPF lip moisturizers containing up to 150% of the labeled Oxybenzone. This event, now terminated, highlights critical quality control failures in contract manufacturing. Procurement and regulatory teams must scrutinize supplier potency testing and formulation adherence to mitigate significant brand and consumer safety risks.

REGULATORY INTELLIGENCE
2020-04-29

Noven Therapeutics' DAYTRANA Recall: Defective Methylphenidate Transdermal System Impacts US Supply

Noven Therapeutics, LLC initiated a Class II recall for 7,957 boxes of DAYTRANA (methylphenidate transdermal system) due to a defective delivery system, specifically issues with mechanical peel and shear. This voluntary, firm-initiated recall, distributed nationwide in the US, highlights critical quality control challenges in transdermal drug delivery. The recall, D-1247-2020, was terminated on June 17, 2024.

REGULATORY INTELLIGENCE
2020-04-29

Noven Therapeutics' Daytrana Methylphenidate Recall: Critical Defect in Transdermal Delivery System

Noven Therapeutics, LLC faced a Class II recall for its Daytrana (methylphenidate transdermal system) due to a defective delivery system failing mechanical peel and shear specifications. This nationwide US recall, initiated March 2020 and terminated June 2024, underscores critical quality control vulnerabilities in specialized drug delivery. Procurement and regulatory teams must scrutinize transdermal patch suppliers to mitigate supply chain risks and ensure patient safety.

CLINICAL & PIPELINE
2020-04-29

COREPHARMA's Generic LISINOPRIL ANDA Approval: Two Decades of Market Presence and Supply Chain Evolution

COREPHARMA secured US FDA approval for its generic LISINOPRIL tablets (ANDA076102) on September 30, 2002, marking a significant entry into the angiotensin-converting enzyme (ACE) inhibitor market. This approval, covering six strengths from 2.5MG to 40MG, has been followed by numerous labeling updates, demonstrating sustained regulatory compliance. The involvement of manufacturers like Heritage Pharmaceuticals and Exelan Pharmaceuticals underscores a robust, multi-entity supply chain for this essential medication, ensuring long-term market availability and cost-effectiveness for procurement and supply chain stakeholders.

CLINICAL & PIPELINE
2020-04-24

tobraDex: Decades of FDA Regulatory Management for a Type 3 New Dosage Form

The FDA's 1988 approval of tobraDex as a Type 3 New Dosage Form, application 50-616, highlights the enduring regulatory lifecycle of mature pharmaceutical products. Subsequent decades of supplemental approvals for labeling and manufacturing underscore critical ongoing compliance demands. This necessitates robust supply chain and regulatory strategies for long-standing market assets.

REGULATORY INTELLIGENCE
2020-04-22

Filltech USA Recalls Dermatone Sunscreen Nationwide Due to Microbial Contamination, Highlighting Supply Chain Vulnerabilities

Filltech USA, LLC initiated a nationwide Class II recall of Dermatone Sunscreen Lotion due to microbial contamination (yeast and bacteria). This event, impacting 4790 tottles and 20,403 tubes, underscores critical quality control and supply chain risks for procurement and regulatory affairs teams. Proactive supplier qualification and robust quality assurance are paramount to mitigate similar disruptions.

REGULATORY INTELLIGENCE
2020-04-22

Aurobindo Pharma USA Inc. Terminates Class II Recall of Gabapentin Capsules Due to CGMP Water Leakage

Aurobindo Pharma USA Inc. has terminated its Class II recall of Gabapentin Capsules, USP 100mg, initiated due to critical CGMP deviations, specifically water leakage in a manufacturing area. This event, affecting 26,625 units distributed nationwide, underscores the imperative for robust supplier qualification and continuous regulatory oversight in pharmaceutical supply chains.

REGULATORY INTELLIGENCE
2020-04-22

FDA Class II Recall: H J Harkins Company's cGMP Deviations Impact Acetaminophen and Codeine Phosphate Supply

H J Harkins Company Inc dba Pharma Pac faced an FDA Class II recall for 9,000 units of Acetaminophen and Codeine Phosphate 300/30 mg tablets due to cGMP deviations. This terminated recall, initiated in 2020, underscores critical supply chain vulnerabilities in pharmaceutical repackaging. Procurement and regulatory teams must enhance due diligence for all partners, ensuring robust quality systems to mitigate disruption risks for essential opioid analgesics distributed in California and Arizona.

REGULATORY INTELLIGENCE
2020-04-22

FDA Recall: B & B Pharmaceuticals' Estradiol Contaminated with Teflon, Highlighting cGMP Lapses

B & B Pharmaceuticals, Inc. initiated a nationwide Class II recall of Estradiol, USP (Non-Micronized) (Hemihydrate) due to Teflon contamination introduced during production. This event underscores critical cGMP deviations impacting product integrity and patient safety. Procurement and regulatory teams must reassess supplier qualification and supply chain vigilance to mitigate risks associated with active pharmaceutical ingredient (API) quality failures.

REGULATORY INTELLIGENCE
2020-04-22

The Medicine Shoppe Pharmacy's Bi-Est Cream Recall Highlights Critical Compounding Processing Control Gaps

The Medicine Shoppe Pharmacy's Class II recall of Bi-Est cream due to 'Lack of Processing Control' in Port Charlotte, Florida, underscores critical quality assurance vulnerabilities in compounded pharmaceuticals. This event signals that procurement and regulatory teams must enhance vigilance over small-scale and local suppliers to mitigate patient safety and supply chain risks.

REGULATORY INTELLIGENCE
2020-04-22

FDA Class II Recall: The Medicine Shoppe Pharmacy Cites Processing Control Lapses for Hormone Compound

The Medicine Shoppe Pharmacy initiated a Class II recall for its Bi-Est/Progesterone/Testosterone compounded hormone product due to a critical 'Lack of Processing Control' at its Port Charlotte, FL facility. This event, terminated in December 2022, underscores the FDA's heightened focus on quality assurance in compounding pharmacies. Decision-makers must reassess supplier qualification protocols and internal oversight for compounded pharmaceutical sourcing to mitigate regulatory and supply chain risks.

REGULATORY INTELLIGENCE
2020-04-22

FDA Class II Recall: NBMA Impurity in Losartan Potassium API Impacts Golden State Medical Supply

Golden State Medical Supply Inc. faced a Class II FDA recall for Losartan Potassium Tablets due to N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) impurity in the API. This event underscores critical supply chain vulnerabilities in API quality control, demanding enhanced due diligence from procurement and stringent CGMP adherence to mitigate regulatory and patient safety risks across the pharmaceutical industry.

CLINICAL & PIPELINE
2020-04-20

Gland Pharma Secures Latest Labeling Approval for Generic Levetiracetam Injection (ANDA206880), Bolstering Supply Chain Stability

Gland Pharma Limited has secured a recent labeling approval for its generic Levetiracetam Injection (ANDA206880), with an effective date of March 26, 2025. This intravenous antiepileptic drug, also manufactured by Dr. Reddy's Laboratories Inc and Sagent Pharmaceuticals, reinforces supply chain resilience and cost-effective access for critical neurological care. Procurement and regulatory teams should note the ongoing product lifecycle management.

CLINICAL & PIPELINE
2020-04-20

FDA Application 021427: A Decade of Sustained Supplemental Approvals and Regulatory Evolution

The FDA has approved numerous supplemental applications for application number 021427, spanning from 2007 to 2021. This consistent regulatory activity, encompassing both efficacy and labeling updates, underscores the continuous lifecycle management required for established pharmaceutical products. For decision-makers, this highlights the critical need for robust regulatory affairs and quality management systems to maintain market access and adapt to evolving clinical data and safety profiles.

REGULATORY INTELLIGENCE
2020-04-15

Avet Pharmaceuticals' Class I Recall of Tetracycline HCL Capsules Signals Critical Quality Control Gaps

Avet Pharmaceuticals initiated a Class I recall for 4,444 bottles of Tetracycline HCL Capsules, 250 mg, due to failed dissolution specifications during long-term testing. This event, terminated in August 2022, highlights significant quality control deficiencies impacting drug efficacy and patient safety, necessitating immediate action for procurement and regulatory teams to reassess supplier quality assurance protocols for essential generic antibiotics.

REGULATORY INTELLIGENCE
2020-04-15

FDA Class II Recall: Innovative Compounding Pharmacy's Testosterone Cypionate Lacked Sterility Assurance

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy initiated a Class II recall for multiple lots of Testosterone Cypionate In Sesame Oil 200mg/ml injectable due to a lack of sterility assurance. This Murrieta, CA-based firm's voluntary action, impacting patients in CA, ME, and TX, underscores critical quality control vulnerabilities in compounded sterile preparations. Procurement and regulatory teams must scrutinize supplier sterility protocols to mitigate supply chain risks.

REGULATORY INTELLIGENCE
2020-04-15

PharMEDium Services' ePHEDrine Sulfate Recall: Sterility Lapses Expose Critical Supply Chain Risks

PharMEDium Services, LLC initiated a Class II recall of 46 lots, including ePHEDrine Sulfate, due to critical sterility assurance failures. This nationwide distribution event, recall number D-1090-2020, highlights significant risks for procurement and regulatory teams relying on compounded sterile products. The termination of this recall on February 14, 2025, underscores the long-term impact of such quality lapses on patient safety and supply chain integrity.

REGULATORY INTELLIGENCE
2020-04-15

FDA Class I Recall: Avet Pharmaceuticals' Tetracycline HCL Capsules Fail Dissolution

Avet Pharmaceuticals, Inc. faced a Class I FDA recall for 17,524 bottles of Tetracycline HCL Capsules, USP, 500 mg, due to failed dissolution specifications during long-term testing. This nationwide recall, initiated on March 23, 2020, underscores critical quality control requirements for generic pharmaceuticals. Procurement and regulatory teams must assess supplier stability data and ensure robust quality agreements to mitigate supply chain disruptions.

REGULATORY INTELLIGENCE
2020-04-15

FDA Class II Recall: Herbal Doctor Remedies' Detoxin-S Deemed Unapproved and Misbranded

Herbal Doctor Remedies faced an FDA Class II recall for Detoxin-S 500mg Capsules due to CGMP deviations, rendering them unapproved new drugs and misbranded. This voluntary, firm-initiated recall, active from March 2020 to January 2024, impacted online and international markets, highlighting critical compliance risks for procurement and regulatory teams globally.

CLINICAL & PIPELINE
2020-04-13

Medtech Products' TAGAMET HB (Cimetidine) Secures Enduring Market Position Through Continuous FDA Approvals

Medtech Products' TAGAMET HB (Cimetidine) achieved a pivotal Type 8 Partial Rx to OTC Switch approval from the FDA on June 19, 1995. This strategic move established Cimetidine as a key over-the-counter histamine H2 receptor antagonist. Subsequent, continuous manufacturing (CMC) and labeling approvals, including a May 2022 update, underscore Medtech's commitment to regulatory compliance and supply chain stability, crucial for sustained market presence.

CLINICAL & PIPELINE
2020-04-10

Teva Pharmaceuticals Secures FDA Labeling Approval for Discontinued Oxaliplatin Injectable (NDA022160)

Teva Pharmaceuticals has received FDA approval for a supplemental labeling application (submission 16) for its Oxaliplatin injectable (NDA022160) on October 31, 2024. Despite this regulatory update, both 50MG/10ML and 100MG/20ML strengths of Teva's Oxaliplatin are officially listed as "Discontinued" by the FDA, indicating no active market presence for this specific product.

REGULATORY INTELLIGENCE
2020-04-08

FDA Class II Recall: Gentamicin Sterility Failure at The Medicine Shoppe Pharmacy Highlights Compounding Risks

The Medicine Shoppe Pharmacy initiated a Class II recall (D-1072-2020) for Gentamicin 80mg/60 mL Irrigation due to lack of sterility assurance. This Florida-centric recall, terminated December 2022, underscores critical quality control vulnerabilities in local pharmaceutical compounding. Procurement and regulatory teams must scrutinize sterility protocols across all suppliers, regardless of scale, to mitigate patient safety risks.

CLINICAL & PIPELINE
2020-04-06

Zydus Pharmaceuticals Secures FDA Approval for Generic Succinylcholine Chloride Injection

Zydus Pharmaceuticals received FDA approval for its generic Succinylcholine Chloride injection (ANDA209467) on May 4, 2018. This approval, with an "AP" therapeutic equivalence rating, designates Zydus's product as a reference standard, enhancing market competition and supply chain resilience for this critical neuromuscular blocker. This offers procurement and supply chain leaders a new, therapeutically equivalent option.

REGULATORY INTELLIGENCE
2020-04-01

Glaxosmithkline Consumer Healthcare Holdings Recalls Advil Allergy & Congestion Relief Over Critical Labeling Omissions

Glaxosmithkline Consumer Healthcare Holdings initiated a Class II recall for 471,024 blisters of Advil Allergy & Congestion Relief due to missing safety warnings on the Drug Facts Panel. This voluntary action, terminated in October 2021, underscores critical labeling compliance risks for OTC products. Procurement and regulatory teams must scrutinize supplier adherence to FDA regulations to prevent market disruptions and safeguard brand integrity.

REGULATORY INTELLIGENCE
2020-04-01

Jubilant Draximage Inc. Faces FDA Class II Recall for DRAXIMAGE DTPA Due to Stability Failures

Jubilant Draximage Inc. initiated a Class II recall for 473 kits of DRAXIMAGE DTPA (Technetium Tc 99m Pentetate Injection) due to failed stability specifications. This FDA-monitored action, impacting U.S. distribution from their Canadian facility, highlights critical quality control needs for radiopharmaceuticals. Procurement and regulatory teams must scrutinize supplier stability data to mitigate supply chain risks.

REGULATORY INTELLIGENCE
2020-04-01

Glaxosmithkline Consumer Healthcare Holdings Initiates Class II Recall of Advil Liqui-Gel Minis Due to Labeling Omission

Glaxosmithkline Consumer Healthcare Holdings voluntarily recalled 446,628 bottles of Advil Liqui-Gel Minis (Ibuprofen 200 mg) across the U.S. and Puerto Rico. This Class II recall, initiated March 16, 2020, was due to the omission of critical safety warnings on the Drug Facts Panel. The event highlights the imperative for rigorous quality control in labeling to prevent market disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2020-04-01

FDA Terminates Class II Recall for Matthew 7:25 Inc dba Thrive Pharmacy's Subpotent Buprenorphine Troches

Matthew 7:25 Inc dba Thrive Pharmacy faced an FDA Class II recall for subpotent Buprenorphine Black Cherry 2 mg Troches, lot 191217A, distributed in Florida. This voluntary, firm-initiated action, terminated in June 2023, highlights critical quality control failures. Procurement and regulatory teams must enhance due diligence for compounded products to mitigate efficacy and safety risks.

REGULATORY INTELLIGENCE
2020-04-01

Nostrum Laboratories Inc. Faces FDA Scrutiny Over Theophylline CGMP Deviations and Labeling Errors

Nostrum Laboratories Inc. initiated a Class II recall of Theophylline (Anhydrous) Extended-Release Tablets due to critical CGMP deviations and incorrect labeling. This event highlights significant quality control failures at their Kansas City, MO facility, impacting supply chain reliability. Decision-makers must assess supplier risk and reinforce robust quality assurance protocols to mitigate similar disruptions and ensure regulatory compliance.

CLINICAL & PIPELINE
2020-03-25

Sandoz Secures Latest FDA Labeling Approval for Generic Dorzolamide Hydrochloride Ophthalmic Solution

Sandoz Inc. has received a supplemental FDA approval on January 23, 2023, for labeling updates concerning its generic Dorzolamide Hydrochloride ophthalmic solution (ANDA078981). This regulatory action, following the original 2009 approval, reinforces Sandoz's commitment to product lifecycle management and compliance in the competitive glaucoma treatment market. For procurement and regulatory teams, this signifies continued market stability and validated product information, ensuring reliable supply and adherence to evolving standards.

REGULATORY INTELLIGENCE
2020-03-25

Fresenius Medical Care's Sodium Chloride Recall Highlights Critical CGMP Sterilization Risks for Injectables

Fresenius Medical Care Holdings, Inc. faced an FDA Class II recall for 32,592 bags of Sodium Chloride 0.9% Injection, USP, due to critical CGMP deviations in sterilization. This event, now terminated, underscores persistent risks in aseptic processing. Procurement and regulatory teams must scrutinize supplier sterilization protocols and quality systems to mitigate supply chain disruptions and ensure patient safety, especially for essential injectables.

REGULATORY INTELLIGENCE
2020-03-25

FDA Class III Recall: Par Pharmaceutical's Prednisone Labeling Error Impacts Nationwide Supply

Par Pharmaceutical Inc. initiated a nationwide Class III recall of 13,008 bottles of Prednisone Tablets, USP 5 mg, due to an incorrect expiration date. This voluntary action, terminated in April 2021, highlights critical labeling quality control gaps. Procurement and regulatory teams must scrutinize supplier quality systems, especially for high-volume generic corticosteroids like Prednisone, to mitigate supply chain disruption and compliance risks.

REGULATORY INTELLIGENCE
2020-03-25

Mylan Pharmaceuticals' Sotalol HCL Recall: Metal Particulate Contamination Impacts US Supply

Mylan Pharmaceuticals initiated a Class II recall for Sotalol HCL Tablets (80 mg) due to metal particulate contamination from its Morgantown, WV facility. This event, impacting 300 bottles nationwide, underscores critical quality control vulnerabilities. Procurement and supply chain leaders must reassess supplier qualification and risk mitigation strategies for essential cardiovascular drugs.

REGULATORY INTELLIGENCE
2020-03-25

Perrigo's Ranitidine Recall: NDMA Contamination Exposes CGMP Lapses and Supply Chain Risks

Perrigo Company PLC initiated a nationwide recall of Ranitidine tablets due to CGMP deviations and potential N-nitrosodimethylamine (NDMA) contamination. This event highlights critical quality control vulnerabilities and broad supply chain exposure across multiple retail brands. Decision-makers must reassess supplier qualification, impurity testing, and diversification strategies to mitigate similar regulatory and commercial risks in the pharmaceutical sector.

REGULATORY INTELLIGENCE
2020-03-25

Sun Pharma's Doxycycline Recall: FDA Cites CGMP Deviations, Highlighting Generic Drug Supply Risks

Sun Pharmaceutical Industries, Inc. faced a Class II recall of Doxycycline Capsules, USP, 75 mg, due to significant CGMP deviations at its manufacturing site. This voluntary action, impacting 624 bottles distributed nationwide, underscores critical quality control vulnerabilities. Procurement and regulatory teams must scrutinize supplier compliance, especially for generic tetracycline-class drugs, to mitigate supply chain disruptions and ensure product integrity.

REGULATORY INTELLIGENCE
2020-03-25

FDA Class I Recall: Med Man Distribution's Bow & Arrow Supplement Contained Undeclared Sildenafil

Med Man Distribution, Inc. initiated a Class I recall of its Bow & Arrow dietary supplement due to undeclared sildenafil, identified by FDA analysis. This event, terminated on October 17, 2023, underscores critical regulatory and supply chain risks for companies distributing products without proper drug approvals, impacting nationwide US markets and demanding enhanced due diligence.

REGULATORY INTELLIGENCE
2020-03-18

American Health Packaging's Ranitidine Recall: NDMA Contamination Exposes Critical CGMP Failures

American Health Packaging's recall of Ranitidine Tablets, USP, 150 mg, due to N-Nitrosodimethylamine (NDMA) exceeding FDA limits highlights critical Current Good Manufacturing Practice (CGMP) deviations. This event underscores the persistent challenge of nitrosamine impurities in the pharmaceutical supply chain, demanding enhanced vigilance from procurement, regulatory, and supply chain leaders to mitigate widespread quality and compliance risks.

REGULATORY INTELLIGENCE
2020-03-18

Redline Pharmacy Solutions Recalls Intrathecal Morphine Sulfate Due to Critical Processing Control Lapses

Redline Pharmacy Solutions initiated a Class II recall of intrathecal Morphine Sulfate due to a critical 'Lack of Processing Controls'. This event, impacting patients in Nebraska, underscores the imperative for robust quality management in compounding pharmacies. Procurement and regulatory teams must scrutinize supplier quality systems for high-risk medications, even from regional distributors, to mitigate patient safety and supply chain risks.

REGULATORY INTELLIGENCE
2020-03-11

Pfizer's Elelyso Recall: Sterility Assurance Failure Impacts Global Supply of Taliglucerase Alfa

Pfizer Inc. initiated a Class II recall of 24,714 vials of Elelyso (taliglucerase alfa) due to loose vial crimps compromising sterility. This voluntary action, impacting US and international markets, highlights critical packaging quality control failures. For decision-makers, it underscores the imperative for robust supplier qualification and vigilant oversight to mitigate supply chain disruptions and ensure product integrity.

REGULATORY INTELLIGENCE
2020-03-11

FDA Class II Recall: Fusion IV Pharmaceuticals' Polidocanol Injection Lacked Sterility Assurance

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical initiated a Class II recall for its Polyoxyl Lauryl Ether (Polidocanol) Injection due to a lack of sterility assurance. This nationwide U.S. and international recall, terminated in December 2023, highlights critical supply chain and regulatory risks for procurement and regulatory affairs teams sourcing injectable pharmaceuticals.

REGULATORY INTELLIGENCE
2020-03-11

Fusion IV Pharmaceuticals' Selenium Injection Recall Highlights Critical Sterility Assurance Risks

Fusion IV Pharmaceuticals, dba Axia Pharmaceutical, faced a Class II recall for its Selenium Injection due to lack of sterility assurance. This event, lasting nearly four years, underscores significant supply chain and regulatory risks for procurement directors and regulatory affairs heads, emphasizing the critical need for robust quality systems in sterile injectable manufacturing across the U.S. and international markets.

CLINICAL & PIPELINE
2020-03-05

Genus Secures FDA Approval for Oral Potassium Chloride Solution (NDA208019)

Genus Lifesciences Inc. secured FDA approval for its Potassium Chloride oral solution (NDA208019) on August 19, 2015. This Type 7 approval formalized market access for Genus's 10MEQ, 15MEQ, 20MEQ, and 40MEQ formulations, an essential electrolyte. Subsequent labeling updates in 2019 and 2020 reinforce regulatory compliance. This event impacts procurement strategies and competitive dynamics in the established electrolyte market.

REGULATORY INTELLIGENCE
2020-03-04

FDA Class I Recall: Taro Pharmaceuticals' Phenytoin Oral Suspension Faces Critical Resuspension Failure

Taro Pharmaceuticals U.S.A., Inc. initiated a Class I recall for Phenytoin Oral Suspension USP due to critical resuspension problems, impacting 29,172 bottles nationwide. This event, now terminated, underscores significant quality control risks for procurement and regulatory teams, necessitating rigorous supplier due diligence and robust supply chain resilience strategies for anti-epileptic agents.

CLINICAL & PIPELINE
2020-02-28

Sanofi Aventis US Secures Latest FDA Labeling Approval for AUBAGIO (Teriflunomide)

Sanofi Aventis US recently secured FDA approval for a supplemental labeling update (SUPPL 18) for its oral drug, AUBAGIO (teriflunomide), on February 11, 2026. This marks another step in the product's lifecycle management since its original New Molecular Entity approval in 2012, impacting regulatory compliance and commercial strategy for procurement and supply chain leaders.

REGULATORY INTELLIGENCE
2020-02-26

American Health Packaging Desmopressin Acetate Recall: GMP Deviation Exposes Packaging Quality Risks

American Health Packaging initiated a Class II recall of 1,879 cartons of Desmopressin Acetate Tablets nationwide due to missing desiccants, a critical GMP deviation. This event, terminated in August 2022, underscores the imperative for robust quality control in pharmaceutical packaging. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate supply chain disruptions and ensure product integrity.

REGULATORY INTELLIGENCE
2020-02-26

NCS Healthcare Glycopyrrolate Recall Highlights Critical Impurity Control Failures for Institutional Supply

NCS Healthcare of Kentucky Inc initiated a Class II recall for 6,929 blister cards of Glycopyrrolate Tabs, USP, 1 mg, due to high out-of-specification results for individual unknown impurities. This event, terminated on February 19, 2021, signals critical quality control deficiencies impacting institutional pharmaceutical supply chains. Procurement and regulatory teams must reassess supplier qualification and product quality assurance protocols for similar drug products.

CLINICAL & PIPELINE
2020-02-25

Teva Pharmaceuticals' Sildenafil Citrate 20mg ANDA: Approval, Discontinuation, and Supply Chain Implications

Teva Pharmaceuticals' ANDA for Sildenafil Citrate 20mg tablets received FDA approval on January 7, 2013, but the product has since been discontinued. This event highlights critical considerations for pharmaceutical procurement and supply chain resilience. Decision-makers must analyze market dynamics that lead to generic discontinuations, assess potential supply chain vulnerabilities, and ensure robust alternative sourcing strategies for essential molecules like Sildenafil Citrate.

CLINICAL & PIPELINE
2020-02-21

Macleods Pharma's Generic Losartan/Hydrochlorothiazide Approval: A Decade of Market Impact and Regulatory Diligence

Macleods Pharmaceuticals Limited secured FDA approval for its generic Losartan Potassium and Hydrochlorothiazide (ANDA202289) on August 9, 2012. This significantly expanded access to an essential hypertension treatment, intensifying market competition and driving price adjustments. The subsequent decade of labeling updates underscores the continuous regulatory commitment required for generic pharmaceutical products, impacting procurement and regulatory strategies.

CLINICAL & PIPELINE
2020-02-21

Accord Healthcare Secures FDA Approval for Zoledronic Acid ANDA205279, Intensifying Generic Competition

Accord Healthcare secured FDA approval for its Zoledronic Acid ANDA205279 on November 28, 2016, marking a significant generic entry. This approval for the intravenous injectable strengthens Accord's market position and intensifies competition for existing Zoledronic Acid suppliers. Procurement directors should leverage this to optimize sourcing strategies and drive cost efficiencies, while regulatory teams note ongoing labeling updates from Accord Healthcare.

REGULATORY INTELLIGENCE
2020-02-19

FDA Class I Recall: Taro Pharmaceuticals' Lamotrigine Contaminated with Enalapril Maleate

Taro Pharmaceuticals U.S.A., Inc. initiated a Class I recall of Lamotrigine Tablets 100 mg due to enalapril maleate cross-contamination. This critical regulatory action, terminated February 2024, underscores severe quality control failures impacting patient safety and supply chain integrity. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate similar high-risk events.

REGULATORY INTELLIGENCE
2020-02-19

FDA Class II Recall: Efficient Laboratories' Rompe Pecho MAX Multi Symptoms Due to Microbial Contamination Signals Heightened Regulatory Scrutiny

Efficient Laboratories, Inc. initiated a Class II recall of 4,080 bottles of Rompe Pecho MAX Multi Symptoms due to microbial contamination. This event, terminated in October 2020, underscores critical compliance risks for non-sterile products. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate similar supply chain disruptions and ensure patient safety.

REGULATORY INTELLIGENCE
2020-02-19

AuroMedics Pharma LLC's Class II Recall of Amoxicillin/Clavulanate Potassium: Supply Chain Contamination Risks

AuroMedics Pharma LLC initiated a Class II recall of Amoxicillin and Clavulanate Potassium tablets due to a nylon cable tie foreign substance. This event, involving a product manufactured by Aurobindo Pharma Limited, underscores critical quality control vulnerabilities in generic pharmaceutical supply chains. Procurement and regulatory teams must enhance due diligence and diversify sourcing for essential antibiotics to mitigate disruption.

REGULATORY INTELLIGENCE
2020-02-19

FDA Class II Recall: Contract Pharmacal's Acetaminophen Commingling Exposes OTC Supply Chain Risks

Contract Pharmacal Corporation faced an FDA Class II recall (D-0858-2020) for Major Extra Strength Acetaminophen Tablets due to commingling with a prenatal supplement. This event, now terminated, highlights critical quality control vulnerabilities in high-volume OTC manufacturing. Procurement directors and supply chain VPs must reinforce supplier qualification and audit processes to mitigate patient safety risks and ensure product integrity across their pharmaceutical portfolios.

CLINICAL & PIPELINE
2020-02-14

LUPIN and SOLA Pharmaceuticals Secure Latest FDA Labeling Approval for Generic Diclofenac Sodium 1.5% Topical Solution

LUPIN, through its manufacturing partner SOLA Pharmaceuticals, has secured another FDA supplemental labeling approval for its generic Diclofenac Sodium 1.5% Topical Solution (ANDA204132) on 2024-11-21. This marks the fifth such approval since the original ANDA in 2015, underscoring continuous regulatory engagement for this key anti-inflammatory. For procurement and regulatory teams, these updates signal ongoing product lifecycle management and potential market adjustments.

REGULATORY INTELLIGENCE
2020-02-12

Unichem Pharmaceuticals Recalls Clonidine HCl: Benzophenone Migration from Packaging Exposes Supply Chain Vulnerabilities

Unichem Pharmaceuticals (USA), Inc. initiated a Class III recall of 19.16 million units of Clonidine Hydrochloride tablets due to Benzophenone migration from container labels. This event underscores critical risks in packaging material quality and supplier oversight. Procurement and regulatory teams must enhance vendor qualification and impurity testing protocols to safeguard product integrity and patient safety.

REGULATORY INTELLIGENCE
2020-02-12

FDA Class II Recall: Ascend Laboratories' Olmesartan Medoxomil Due to Unapproved API Source Change

Ascend Laboratories LLC initiated a Class II recall of Olmesartan Medoxomil Tablets 20 mg due to cGMP deviations. The product was released with an unapproved alternate API source, highlighting critical regulatory and supply chain risks. This event underscores the imperative for robust change control and validated API sourcing strategies to maintain market access and patient safety.

REGULATORY INTELLIGENCE
2020-02-12

FDA Terminates Spectrum Laboratory Products' Ranitidine HCl Recall Amid NDMA Contamination

The FDA has terminated Spectrum Laboratory Products' Class II recall of Ranitidine Hydrochloride (powder), USP, initiated due to NDMA impurity and CGMP deviations. This event, impacting US, Canadian, and UAE markets, underscores persistent nitrosamine risks in API supply chains. Procurement and regulatory teams must enhance supplier vetting and analytical testing to mitigate future disruptions from similar quality failures.

CLINICAL & PIPELINE
2020-02-10

Hospira's Morphine Sulfate: 2020 Labeling Approval Reinforces Ongoing Regulatory Compliance for Generic Analgesics

Hospira, Inc. received a U.S. Food and Drug Administration (FDA) supplemental approval on February 10, 2020, for a labeling update to its generic Morphine Sulfate injectable (ANDA073509). This regulatory action for the long-standing analgesic, originally approved in 1992, underscores ongoing compliance requirements for mature pharmaceutical products. Decision-makers must recognize the continuous need for robust regulatory affairs and supply chain management to maintain market access and product integrity.

CLINICAL & PIPELINE
2020-02-07

Actavis Labs FL Inc.'s Ramelteon Generic: Navigating Labeling Updates and Market Access for Insomnia Treatment

Actavis Labs FL Inc. secured its initial generic approval for RAMELTEON (ANDA091610) in August 2015, followed by significant labeling updates in 2020 and 2023. This highlights the ongoing regulatory demands for generic manufacturers and the strategic importance of maintaining product compliance and supply chain efficiency in the competitive melatonin receptor agonist market for insomnia.

REGULATORY INTELLIGENCE
2020-02-05

FDA Class II Recall: Pharmaceutical Associates' Subpotent Nystatin Oral Suspension Impacts US Supply

Pharmaceutical Associates, Inc. initiated a Class II recall of Nystatin Oral Suspension due to subpotency, affecting 6,288 bottles distributed nationwide. This event highlights critical quality control vulnerabilities in pharmaceutical manufacturing, demanding immediate attention from procurement and regulatory teams to ensure product efficacy and patient safety within the US market.

REGULATORY INTELLIGENCE
2020-02-05

FDA Class II Recall: MPRX, Inc. dba Medical Park Pharmacy Recalls Squaric Acid Solution Over Expired Components

MPRX, Inc. dba Medical Park Pharmacy initiated a Class II recall for one bottle of Squaric Acid 0.1% Topical Solution (Clinic) on December 18, 2019. The recall, terminated December 13, 2022, stemmed from compounding with expired components and labeling deficiencies. This highlights the critical need for rigorous quality control and adherence to Good Manufacturing Practices, even for small-scale compounding operations, to mitigate patient safety risks and regulatory penalties.

CLINICAL & PIPELINE
2020-02-04

Lupin Secures Labeling Approval for Generic Contraceptive VYFEMLA Amidst Ongoing Quality Scrutiny

Lupin Pharmaceuticals secured supplemental labeling approval for its generic oral contraceptive, VYFEMLA (NORETHINDRONE AND ETHINYL ESTRADIOL), on April 29, 2022. This regulatory update ensures continued market access for the AB-rated product. However, procurement and supply chain leaders must consider Lupin's 'watch' risk band and history of quality recalls, necessitating enhanced supplier due diligence and diversified sourcing strategies for critical generic molecules.

REGULATORY INTELLIGENCE
2020-01-29

H J Harkins Pharma Pac Ranitidine Recall: NDMA Impurity Exposes Critical CGMP Lapses and Supply Chain Risks

H J Harkins Company Inc dba Pharma Pac initiated a Class II recall of Ranitidine 150 mg Tablets due to NDMA impurity and CGMP deviations. This event, impacting distribution in CA, FL, NC, and SC, underscores persistent quality control challenges in pharmaceutical manufacturing and demands rigorous supply chain vigilance from industry leaders.

REGULATORY INTELLIGENCE
2020-01-29

Hikma Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Due to Critical Labeling Error

Hikma Pharmaceuticals USA Inc. initiated a Class III recall of methylPREDNISolone Sodium Succinate for Injection due to incorrect reconstitution instructions on vial labels. This regulatory event highlights critical quality control vulnerabilities, necessitating immediate review of supply chain integrity and internal labeling protocols for procurement and regulatory affairs teams to mitigate patient safety risks and ensure compliance.

REGULATORY INTELLIGENCE
2020-01-29

FDA Class II Recall: Tuscano and Delucia Group's Entropic Labs SARM RAD-140 Marketed Without Approval

Tuscano and Delucia Group (DBA Entropic Labs) initiated a Class II recall for SARM RAD-140 capsules, distributed nationwide. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), containing Selective Androgen Receptor Modulators (SARMs). This highlights critical regulatory compliance failures for procurement and regulatory affairs teams.

CLINICAL & PIPELINE
2020-01-27

Alembic Pharmaceuticals Strengthens Generic Dermatology Portfolio with FDA Approval for Clobetasol Propionate Cream

Alembic Pharmaceuticals secured FDA approval for its generic Clobetasol Propionate 0.05% Cream (ANDA213291) on January 27, 2020. This strengthens Alembic's dermatological footprint, following a shampoo formulation approval, intensifying competition for existing suppliers. Procurement directors should leverage this for cost savings, while supply chain VPs note Alembic's low-risk manufacturing profile, enhancing market access for this high-potency corticosteroid.

CLINICAL & PIPELINE
2020-01-24

FDA Grants Priority Efficacy Approval for Application 202293, Signaling Expanded Clinical Utility

The FDA has granted a Priority Review approval for Efficacy Supplement 31 to application 202293 on June 12, 2024. This significant regulatory milestone indicates an expansion of the product's approved clinical utility. Decision-makers must assess the implications of this efficacy update on market dynamics, competitive positioning, and future supply chain requirements for this undisclosed therapeutic.

CLINICAL & PIPELINE
2020-01-24

Merck's SEGLUROMET: Strategic Implications of a Type 4 New Combination Approval and Ongoing Labeling Updates for Diabetes Management

Merck Sharp & Dohme LLC's SEGLUROMET, a fixed-dose combination of Ertugliflozin and Metformin Hydrochloride, received its original Type 4 New Combination approval from the FDA on December 19, 2017. This strategic approval, coupled with continuous labeling updates, including a forthcoming one in December 2024, underscores Merck's commitment to the Type 2 Diabetes market and presents critical considerations for pharmaceutical supply chain and regulatory affairs.

REGULATORY INTELLIGENCE
2020-01-22

AVKARE Inc. Dutasteride Recall: Impurity Failures Highlight Critical Supply Chain Vulnerabilities

AVKARE Inc. initiated a Class II recall of 3,989 cartons of Dutasteride Capsules, 0.5 mg, due to high out-of-specification impurity levels. This nationwide U.S. distribution event, terminated in 2021, underscores the critical need for robust quality control and diversified sourcing strategies for procurement directors and supply chain VPs to mitigate disruption and ensure patient safety.

REGULATORY INTELLIGENCE
2020-01-22

McGuff Compounding Pharmacy's Lipoic Acid Injection Recall: Critical Lessons for Sterile Compounding Supply Chains

McGuff Compounding Pharmacy Services, Inc. initiated a Class II recall for 146 vials of Lipoic Acid Injection due to particulate matter. This event, now terminated, underscores persistent quality control challenges in sterile compounding. Procurement and regulatory teams must rigorously vet suppliers to mitigate patient safety risks and ensure supply chain integrity for critical compounded injectables.

REGULATORY INTELLIGENCE
2020-01-22

Assurance Infusion Initiates Nationwide Class II Recall of BUP/SUF Injection Due to Sterility Assurance Lapses

Assurance Infusion has executed a Class II nationwide recall of its BUP 20MG/SUF 1000MCG/ML INJ in 20 mL syringes, Lot 12172019@10, due to critical lack of sterility assurance. This event, initiated December 20, 2019, and terminated October 27, 2021, underscores significant risks in parenteral drug manufacturing. Procurement and regulatory teams must scrutinize compounding pharmacy quality systems to mitigate supply chain vulnerabilities and patient safety risks.

REGULATORY INTELLIGENCE
2020-01-22

Sigan Industries Inc. Recalls 11,004 Bottles of Eczema Skin Relief Lotion Due to Microbial Contamination

Sigan Industries Inc., based in Brampton, Canada, initiated a Class III recall of 11,004 bottles of Eczema Skin Relief Lotion due to microbial contamination. This voluntary, firm-initiated action, terminated in August 2022, highlights critical quality control challenges for non-sterile topical products. Procurement and regulatory teams must scrutinize supplier quality systems to mitigate similar supply chain disruptions and ensure product safety.

REGULATORY INTELLIGENCE
2020-01-22

FDA Class II Recall: Assurance Infusion's LIPO B Sterility Breach Impacts US Supply Chain

Assurance Infusion initiated a Class II recall (D-0749-2020) for its LIPO B product due to a critical lack of sterility assurance. This Houston, TX-based manufacturer's voluntary action, affecting nationwide U.S. distribution, highlights persistent quality control challenges in specialty pharmaceuticals. The recall, active from December 2019 to October 2021, underscores the imperative for robust supplier qualification and stringent sterility protocols to mitigate supply chain risks.

REGULATORY INTELLIGENCE
2020-01-22

Motto International Corp's Class I Recall: Undeclared Tadalafil in Unapproved Drug Exposes Critical Supply Chain Risks

Motto International Corp's Class I recall of Bull Platinum 30000 Capsules highlights critical regulatory non-compliance. The FDA found the product, distributed in Texas, contained undeclared tadalafil and was marketed without required NDA/ANDA approval. This event underscores the imperative for robust vendor qualification and rigorous analytical testing within pharmaceutical supply chains, particularly for products lacking transparent regulatory pathways, to mitigate significant health and business risks.

REGULATORY INTELLIGENCE
2020-01-22

Sun Pharma Recalls Testosterone Cypionate Due to cGMP Deviations, Impacting US Supply

Sun Pharmaceutical Industries, Inc. initiated a Class II recall (D-0787-2020) of Testosterone Cypionate for Injection, USP, distributed across the US. The action stemmed from cGMP deviations, as released lots were manufactured under conditions similar to a rejected OOS lot. This event, terminated in August 2020, underscores critical supply chain and quality assurance challenges for procurement and regulatory leaders.

CLINICAL & PIPELINE
2020-01-21

Dr. Reddy's Laboratories' Divalproex Sodium ANDA: A Decade of Sustained Generic Market Presence and Regulatory Activity

Dr. Reddy's Laboratories Ltd. secured its Abbreviated New Drug Application (ANDA) for Divalproex Sodium (ANDA078979) on January 23, 2009, establishing a long-standing presence in the generic market. This approval, followed by numerous labeling supplements, underscores the mature competitive landscape and the continuous regulatory compliance demands for this oral prescription drug, impacting procurement and regulatory strategies.

REGULATORY INTELLIGENCE
2020-01-15

FDA Class II Recall: Appco Pharma's Ranitidine Capsules Pulled Over NDMA Impurity and CGMP Failures

Appco Pharma LLC initiated a Class II recall of Ranitidine Capsules 300 mg due to N-nitrosodimethylamine (NDMA) impurity in the API, stemming from CGMP deviations. This event, impacting 1,632 bottles distributed across the U.S., underscores critical supply chain vulnerabilities and the imperative for robust quality control and diversified sourcing strategies for procurement and regulatory teams.

REGULATORY INTELLIGENCE
2020-01-15

FDA Class II Recall: Glenmark Ranitidine Tablets Pulled Nationwide Over NDMA Impurity and CGMP Deviations

Glenmark Pharmaceuticals Inc., USA initiated a nationwide Class II recall of 500,960 bottles of Ranitidine Tablets USP 300 mg due to NDMA impurity and CGMP deviations. This event, originating from its Indian manufacturing facility, necessitates immediate action from procurement and regulatory teams to reassess supplier quality and ensure robust impurity control protocols.

REGULATORY INTELLIGENCE
2020-01-15

FDA Scrutiny: Glenmark Ranitidine Recall Highlights Critical CGMP Deviations and NDMA Contamination

Glenmark Pharmaceuticals Inc., USA initiated a nationwide Class II recall of over 1.3 million bottles of Ranitidine Tablets USP 300 mg due to CGMP deviations and NDMA impurity. This event underscores critical supply chain and quality control risks, demanding immediate action from procurement and regulatory teams to ensure product safety and supply continuity.

REGULATORY INTELLIGENCE
2020-01-15

Idelle Labs Faces FDA Recall for Undeclared Active Ingredient in SURE Antiperspirant

Idelle Labs initiated a Class III recall for SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant due to an undeclared active ingredient. The FDA-terminated recall, D-0783-2020, highlights critical labeling and quality control failures. This event underscores the imperative for robust supplier qualification and rigorous internal verification processes for all chemical and life science product distributors.

REGULATORY INTELLIGENCE
2020-01-08

Lupin Pharmaceuticals Recalls Bimatoprost Ophthalmic Solution Over Impurity Failures, Highlighting Supply Chain Risks

Lupin Pharmaceuticals Inc. initiated a Class III recall of 2,130 bottles of Bimatoprost Ophthalmic Solution, 0.03%, due to out-of-specification impurity levels from its Pithampur, India facility. This event underscores critical quality control vulnerabilities for procurement and regulatory teams, necessitating enhanced supplier due diligence and robust incoming material inspection protocols to mitigate supply chain disruption.

REGULATORY INTELLIGENCE
2020-01-08

Akorn's Myorisan Recall: Class II Mispackaging Exposes Critical Pharmaceutical Quality Control Gaps

Akorn, Inc. initiated a Class II recall for 4,206 boxes of MYORISAN (isotretinoin capsules, 20mg) due to unit dose mispackaging, where 40mg blister cards were found in 20mg cartons. This event, terminated in August 2022, underscores persistent quality control challenges in pharmaceutical manufacturing, impacting patient safety and supply chain integrity for procurement and regulatory leaders.

REGULATORY INTELLIGENCE
2020-01-08

FDA Class I Recall: Natures Rx's Undeclared Sildenafil in Male Enhancement Product Exposes Critical Supply Chain Risks

Natures Rx's Class I recall of "Silver Bullet, Get Bigger and Harder" due to undeclared Sildenafil and unapproved new drug status highlights severe regulatory and supply chain risks. Procurement and regulatory teams must enhance supplier vetting and product testing to mitigate exposure to adulterated products and safeguard market access and brand integrity.

CLINICAL & PIPELINE
2020-01-02

Generic Rasagiline Mesylate Approval by ALKEM LABS LTD Bolsters Parkinson's Treatment Market

ALKEM LABS LTD secured FDA approval for its generic Rasagiline Mesylate (ANDA201889) in 0.5mg and 1mg oral tablets, manufactured by Ascend Laboratories, LLC and NorthStar RxLLC. This 2017 approval, with subsequent labeling updates, significantly enhances market competition for Parkinson's disease treatment. Procurement and regulatory teams should note the expanded supply options and potential pricing shifts.

REGULATORY INTELLIGENCE
2020-01-01

Pharmedium Services Recalls Subpotent Norepinephrine Bitartrate: Critical Supply Chain Alert

Pharmedium Services, LLC initiated a nationwide Class III recall for 864 bags of subpotent NORepinephrine Bitartrate Injection. This critical "High Alert" drug, essential for cardiovascular support, posed significant patient safety risks due to compromised efficacy. Procurement and regulatory teams must scrutinize supplier quality and robust testing protocols for compounded sterile products, ensuring consistent potency for vital medicines.

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