Drug Enforcement D-0151-2025

CGMP deviations: out of specifications for assay

Status

Ongoing

Classification

Class II

Report Date

December 25, 2024

Termination Date

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Product Information

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
Product quantity
33,659 retail boxes in US
Reason for recall
CGMP deviations: out of specifications for assay
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA and 2 Distributors in Hong Kong

Location & Firm

Recalling firm
Apothecus Pharmaceutical Corp.
Address
485 S Broadway Ste 27

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0151-2025
Event ID
95824
Recall initiation date
November 22, 2024
Center classification date
December 17, 2024
Code info
Lot: 3A001/3A001A, Exp: 07/25
More code info
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