Drug 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
D-0151-2025
Product summary
- Event
- Event 95824
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 33,659 retail boxes in US
- Official record key
drug-enforcement:D-0151-2025
Official wording
Reason: CGMP deviations: out of specifications for assay
Code information: Lot: 3A001/3A001A, Exp: 07/25
Distribution pattern: Nationwide in the USA and 2 Distributors in Hong Kong
Derived failure modes
-
Manufacturing or process control
CGMP deviations