FDA recall D-0623-2020

Apothecus Pharmaceutical Corp. · Class III · 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.

Reason for recall

Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable

Distribution

Nationwide in the US and Canada

Key facts

Status
Terminated
Initiation date
2019-11-25
Report date
2019-12-25
Termination date
2024-09-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hicksville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0623-2020