FDA recall D-0151-2025

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

Reason for recall

CGMP deviations: out of specifications for assay

Distribution

Nationwide in the USA and 2 Distributors in Hong Kong

Key facts

Status

Ongoing

Initiation date

2024-11-22

Report date

2024-12-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hicksville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0151-2025