FDAHealthNovember 22, 2024
Apothecus Pharmaceutical Corp. — VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY
⚠️ CGMP deviations: out of specifications for assay
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 22, 2024
Nationwide in the USA and 2 Distributors in Hong Kong
What's affected?
- Product
- VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779, NDC 52925-512-10
- Lot code
- 3A001/3A001A
Additional details
Lot: 3A001/3A001A, Exp: 07/25
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 33,659 retail boxes in US.
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