ChlorproMAZINE Hydrochloride Tablets recalled over manufacturing violations
- Recall date
- March 11, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Glenmark Pharmaceuticals Inc., USA recalls chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceu…
- Recall number
- D-0309-2025
- FDA classification
- Class II
- Brand / firm
- Glenmark Pharmaceuticals Inc., USA
- Sold / distributed
- Nationwide in the USA and PR
Why it was recalled
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
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