D-0151-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 25, 2024
- Initiation Date
- November 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,659 retail boxes in US
Product Description
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
Reason for Recall
CGMP deviations: out of specifications for assay
Distribution Pattern
Nationwide in the USA and 2 Distributors in Hong Kong
Code Information
Lot: 3A001/3A001A, Exp: 07/25