The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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
Reason
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Classification
Class II
Status
Ongoing
Lot
Lot#: N02114, Exp 12/31/2025
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Class II Recall | MedicineWatch US