Recall D-0009-2026
Recalling firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, TN
Product
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061
Reason for recall
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit