Wed Apr 23 2025
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
---|---|---|---|
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61 | Major Pharmaceuticals | Nationwide USA | 133 cartons |