ChemLifeIntel/Companies/APOTHECUS PHARMACEUTICAL CORP.

APOTHECUS PHARMACEUTICAL CORP.

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INTELLIGENCE

Showing 2 of 2 briefs on APOTHECUS PHARMACEUTICAL CORP.

REGULATORY INTELLIGENCE·Warning Letter

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.

90-Day Activity

APOTHECUS PHARMACEUTICAL CORP.VCF CONTRACEPTIVE

CMCatherine Morrow· Senior Regulatory Intelligence Analyst

2024-12-25

REGULATORY INTELLIGENCE·Warning Letter

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.

90-Day Activity

APOTHECUS PHARMACEUTICAL CORP.VCF CONTRACEPTIVE

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2024-04-03