PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: December 25, 2024 Initiated: November 22, 2024 #D-0151-2025

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

Details

Units Affected
33,659 retail boxes in US
Distribution
Nationwide in the USA and 2 Distributors in Hong Kong
Location
Hicksville, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Apothecus Pharmaceutical Corp.. Units affected: 33,659 retail boxes in US.
Why was this product recalled?
CGMP deviations: out of specifications for assay
Which agency issued this recall?
This recall was issued by the FDA Drug on December 25, 2024. Severity: Moderate. Recall number: D-0151-2025.