The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Dist
Recalled April 23, 2025 · FDA recall D-0366-2025 · The Harvard Drug Group LLC
Hazard
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit · FDA Class II
Units
133 cartons
Sold at
Nationwide USA
Description
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Product
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
Manufacturer(s)
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →