Recalls / Class II
Class IID-0427-2024
Product
VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01
- Brand name
- Vcf Contraceptive
- Generic name
- Nonoxynol-9
- Active ingredient
- Nonoxynol-9
- Route
- Vaginal
- NDC
- 52925-112
- FDA application
- 505G(a)(3)
- Affected lot / code info
- Lot # 1G008A/1G00804722, Exp 07/31/25
Why it was recalled
cGMP Diviations
Recalling firm
- Firm
- Apothecus Pharmaceutical Corp.
- Manufacturer
- APOTHECUS PHARMACEUTICAL CORP.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 485 S Broadway Ste 27, N/A, Hicksville, New York 11801-5071
Distribution
- Quantity
- 17,280 paper cartons
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2024-03-21
- FDA classified
- 2024-03-28
- Posted by FDA
- 2024-04-03
- Terminated
- 2024-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0427-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.