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D-0151-2025Class 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
Ongoing
Report date
2024-12-25
Distribution
Nationwide in the USA and 2 Distributors in Hong Kong
Firm state
NY
Product quantity
33,659 retail boxes in US
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

CGMP deviations: out of specifications for assay

Product description

VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779, NDC 52925-512-10

Code / lot info

Lot: 3A001/3A001A, Exp: 07/25

Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →

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 →