Apothecus Pharmaceutical product recalled over manufacturing violations
- Recall date
- November 22, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Apothecus Pharmaceutical Corp. recalls VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By:…
- Recall number
- D-0151-2025
- FDA classification
- Class II
- Brand / firm
- Apothecus Pharmaceutical Corp.
- Sold / distributed
- Nationwide in the USA and 2 Distributors in Hong Kong
Why it was recalled
CGMP deviations: out of specifications for assay
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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
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