Why it was recalled
cGMP Diviations
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 1G008A/1G00804722, Exp 07/31/25
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0427-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 21, 2024
- FDA report date
- Apr 3, 2024
- Quantity
- 17,280 paper cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apothecus Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-0427-2024, exactly as published.
Show all FDA fields
- City
- Hicksville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 94277
- Address
- 485 S Broadway Ste 27
- Code information
- Lot # 1G008A/1G00804722, Exp 07/31/25
- Postal code
- 11801-5071
- Report date
- Apr 3, 2024
- Product type
- Drugs
- Recall number
- D-0427-2024
- Classification
- Class II
- Recalling firm
- Apothecus Pharmaceutical Corp.
- Product quantity
- 17,280 paper cartons
- Termination date
- Sep 9, 2024
- Reason for recall
- cGMP Diviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Mar 21, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 28, 2024