FDA-Drug2025-04-09Class II
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
Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Sold states
Nationwide in the USA and PR
Affected count
8160 bottles
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0309-2025Don't want to check this manually?
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