Recalls / Class II
Class IID-0151-2025
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
- Brand name
- Vcf Contraceptive Pre-filled Applicators
- Generic name
- Nonoxynol-9
- Active ingredient
- Nonoxynol-9
- Route
- Vaginal
- NDC
- 52925-512
- FDA application
- 505G(a)(3)
- Affected lot / code info
- Lot: 3A001/3A001A, Exp: 07/25
Why it was recalled
CGMP deviations: out of specifications for assay
Recalling firm
- Firm
- Apothecus Pharmaceutical Corp.
- Manufacturer
- APOTHECUS PHARMACEUTICAL CORP
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 485 S Broadway Ste 27, Hicksville, New York 11801-5071
Distribution
- Quantity
- 33,659 retail boxes in US
- Distribution pattern
- Nationwide in the USA and 2 Distributors in Hong Kong
Timeline
- Recall initiated
- 2024-11-22
- FDA classified
- 2024-12-17
- Posted by FDA
- 2024-12-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0151-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.