FDAClass IIDecember 25, 2024

VCF, Vaginal Contraceptive Gel, Birth Control, 10 recall: CGMP Deviations

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

Why was VCF, Vaginal Contraceptive Gel, Birth Control, 10 recalled?

CGMP deviations: out of specifications for assay

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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
Recalling firm
Apothecus Pharmaceutical Corp.
Quantity
33,659 retail boxes in US
Distribution
Nationwide in the USA and 2 Distributors in Hong Kong
Recall date
December 25, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls