ChemLifeIntel/Companies/AmeriSource Bergen

AmeriSource Bergen

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Showing 7 of 7 briefs on AmeriSource Bergen

REGULATORY INTELLIGENCE·Recall

Amerisource Health Services Initiates Class II Recall of Oxycodone Hydrochloride Due to Packaging Defects

Amerisource Health Services LLC initiated a Class II recall for 31,676 packages of Oxycodone Hydrochloride Tablets due to defective blister card seals. This nationwide recall, impacting lots 1027932 and 1028360, poses significant supply chain risks for procurement and regulatory teams. Businesses must assess their exposure to packaging quality vulnerabilities and reinforce supplier qualification protocols to mitigate disruption and ensure patient safety.

90-Day Activity

AmeriSource BergenOxycodone Hydrochloride

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2026-02-18

REGULATORY INTELLIGENCE·Recall

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.

90-Day Activity

AmeriSource BergenPrazosin Hydrochloride

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2025-11-05

REGULATORY INTELLIGENCE·Recall

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.

90-Day Activity

AmeriSource BergenSucralfate

RMRohan Mehta· Senior Supply Chain Intelligence Analyst

2025-10-22 Recall

REGULATORY INTELLIGENCE·Recall

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.

90-Day Activity

AmeriSource BergenDuloxetine Hydrochloride

CMCatherine Morrow· Senior Regulatory Intelligence Analyst

2025-01-01 Recall

REGULATORY INTELLIGENCE·Warning Letter

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.

90-Day Activity

AmeriSource BergenDuloxetine Hydrochloride

PSPriya Subramaniam· Intelligence Analyst

2024-12-11▲ Trending signal

REGULATORY INTELLIGENCE·Recall

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.

90-Day Activity

AmeriSource BergenPotassium Iodide

RMRohan Mehta· Senior Supply Chain Intelligence Analyst

2024-08-07 Recall

REGULATORY INTELLIGENCE·Recall

AmeriSource Bergen Recalls Ifosfamide Injection Over Cold Chain Failure, Highlighting Distribution Risks

AmeriSource Bergen initiated a Class II recall of Ifosfamide Injection 3g/60 mL due to temperature abuse at its distribution centers. This 2013 event, involving 60 vials, underscores critical cold chain vulnerabilities for oncology drugs. The incident highlights the imperative for robust distributor oversight and continuous cold chain integrity monitoring to mitigate patient safety risks and supply disruptions.

90-Day Activity

AmeriSource BergenIfosfamideHSN 3004.90

CMCatherine Morrow· Senior Regulatory Intelligence Analyst

2013-10-09▲ Trending signal