Why it was recalled
Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
Product description
VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack with 36 cans in a nested container. Net wt 0.6 oz (17g) per can. NDC 52925-312-06, Distributed By: Apothecus Pharmaceutical Corp. Oyster Bay, NY 11771.
Lot numbers, UPCs & expiration codes
Lot # 31560, 31561 exp. date 06/2021
Where it was sold
Nationwide in the US and Canada
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-0623-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 25, 2019
- FDA report date
- Dec 25, 2019
- Quantity
- a) 34,417 cans b)142 cases 5,112 cans
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apothecus Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-0623-2020, exactly as published.
Show all FDA fields
- City
- Hicksville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 84289
- Address
- 485 S Broadway Ste 27
- Code information
- Lot # 31560, 31561 exp. date 06/2021
- Postal code
- 11801-5071
- Report date
- Dec 25, 2019
- Product type
- Drugs
- Recall number
- D-0623-2020
- Classification
- Class III
- Recalling firm
- Apothecus Pharmaceutical Corp.
- Product quantity
- a) 34,417 cans b)142 cases 5,112 cans
- Termination date
- Sep 24, 2024
- Reason for recall
- Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack with 36 cans in a nested container. Net wt 0.6 oz (17g) per can. NDC 52925-312-06, Distributed By: Apothecus Pharmaceutical Corp. Oyster Bay, NY 11771.
- Distribution pattern
- Nationwide in the US and Canada
- Recall initiation date
- Nov 25, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 19, 2019