Lupin Pharmaceuticals Inc. recalls clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florid…
- Recall date
- June 27, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0537-2025
- FDA classification
- Class II
- Brand / firm
- Lupin Pharmaceuticals Inc.
- Sold / distributed
- Nationwide.
Why it was recalled
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
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