Drug 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.
D-0623-2020
Product summary
- Event
- Event 84289
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 34,417 cans b)142 cases 5,112 cans
- Official record key
drug-enforcement:D-0623-2020
Official wording
Reason: Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
Code information: Lot # 31560, 31561 exp. date 06/2021
Distribution pattern: Nationwide in the US and Canada
Derived failure modes
-
Unknown
Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable