Recalls / Class III
Class IIID-0623-2020
Product
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.
- Affected lot / code info
- Lot # 31560, 31561 exp. date 06/2021
Why it was recalled
Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
Recalling firm
- Firm
- Apothecus Pharmaceutical Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 485 S Broadway Ste 27, Hicksville, New York 11801-5071
Distribution
- Quantity
- a) 34,417 cans b)142 cases 5,112 cans
- Distribution pattern
- Nationwide in the US and Canada
Timeline
- Recall initiated
- 2019-11-25
- FDA classified
- 2019-12-19
- Posted by FDA
- 2019-12-25
- Terminated
- 2024-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0623-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.