Glenmark Pharmaceuticals Inc., USA recalls chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals

Recalled January 1, 2025 · FDA recall D-0160-2025 · Glenmark Pharmaceuticals Inc., USA

Hazard

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. · FDA Class II

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Description

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Product

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01

Manufacturer(s)

Glenmark Pharmaceuticals Inc., USA

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →