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D-0427-2024Class II

Apothecus Pharmaceutical Corp.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Apothecus Pharmaceutical Corp.
Product type
Drug
Status
Terminated
Report date
2024-04-03
Distribution
USA nationwide.
Firm state
NY
Product quantity
17,280 paper cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

cGMP Diviations

Product description

VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01

Code / lot info

Lot # 1G008A/1G00804722, Exp 07/31/25

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →