VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By:
Summary
The FDA issued a Class II for VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt by Apothecus Pharmaceutical Corp.. Reason: CGMP deviations: out of specifications for assay.
Details
Source
Drug Recall
External ID
D-0151-2025
Action Date
2024-12-25
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot: 3A001/3A001A, Exp: 07/25
Quantity Affected: 33,659 retail boxes in US
Reason for Recall
CGMP deviations: out of specifications for assay
Distribution
Nationwide in the USA and 2 Distributors in Hong Kong
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-22
Company
Hicksville, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 75 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Apothecus Pharmaceutical Corp. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Apothecus Pharmaceutical Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Apothecus Pharmaceutical Corp. have FDA actions?
Apothecus Pharmaceutical Corp. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0151-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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