ChemLifeIntel/Companies/Imprimis NJOF, LLC

Imprimis NJOF, LLC

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INTELLIGENCE

Showing 6 of 6 briefs on Imprimis NJOF, LLC

REGULATORY INTELLIGENCE·Recall

Imprimis NJOF Recalls Tri-Moxi+ Intraocular Injections Nationwide Due to Glass Particulate Contamination

Imprimis NJOF, LLC initiated a Class II nationwide recall of 6,280 Tri-Moxi+ intraocular injection syringes due to glass-like particulate matter. This event underscores critical quality control vulnerabilities for procurement directors and regulatory affairs heads. Businesses must assess supply chain risks for ophthalmic products, diversify sourcing, and enhance supplier qualification to mitigate future disruptions from similar contamination issues.

90-Day Activity

Imprimis NJOF, LLC

RMRohan Mehta· Senior Supply Chain Intelligence Analyst

2026-01-14 Recall

REGULATORY INTELLIGENCE·Recall

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.

90-Day Activity

Imprimis NJOF, LLC

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2025-07-30

REGULATORY INTELLIGENCE·Recall

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.

90-Day Activity

Imprimis NJOF, LLCHSN 3004.90

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2025-07-30

REGULATORY INTELLIGENCE·Recall

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.

90-Day Activity

Imprimis NJOF, LLC

PSPriya Subramaniam· Intelligence Analyst

2024-06-19

REGULATORY INTELLIGENCE·Recall

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.

90-Day Activity

Imprimis NJOF, LLCDexamethasone

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2024-06-05

REGULATORY INTELLIGENCE·Recall

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.

90-Day Activity

Imprimis NJOF, LLC

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2024-05-08