D-0151-2025 Class II Ongoing

Recalled by Apothecus Pharmaceutical Corp. — Hicksville, NY

Recall Details

Product Type
Drugs
Report Date
December 25, 2024
Initiation Date
November 22, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
33,659 retail boxes in US

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

Reason for Recall

CGMP deviations: out of specifications for assay

Distribution Pattern

Nationwide in the USA and 2 Distributors in Hong Kong

Code Information

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