Class II

Drug Recall: 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

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · April 14, 2025

Reason for Recall

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Distribution

Nationwide USA

States Affected

NATIONWIDE

Quantity Affected

133 cartons

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0366-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.