Why it was recalled
CGMP deviations: out of specifications for assay
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
Lot numbers, UPCs & expiration codes
Lot: 3A001/3A001A, Exp: 07/25
Where it was sold
Nationwide in the USA and 2 Distributors in Hong Kong
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-0151-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 22, 2024
- FDA report date
- Dec 25, 2024
- Quantity
- 33,659 retail boxes in US
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apothecus Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-0151-2025, exactly as published.
Show all FDA fields
- City
- Hicksville
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 95824
- Address
- 485 S Broadway Ste 27
- Code information
- Lot: 3A001/3A001A, Exp: 07/25
- Postal code
- 11801-5071
- Report date
- Dec 25, 2024
- Product type
- Drugs
- Recall number
- D-0151-2025
- Classification
- Class II
- Recalling firm
- Apothecus Pharmaceutical Corp.
- Product quantity
- 33,659 retail boxes in US
- Reason for recall
- CGMP deviations: out of specifications for assay
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA and 2 Distributors in Hong Kong
- Recall initiation date
- Nov 22, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 17, 2024