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.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 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 | SafeCheck