FDA-Drug2025-10-15Class II
Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Hazard
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Sold states
Nationwide
Affected count
1394 blister packs
Manufactured in
341 Mason Rd, La Vergne, TN, United States
Products
Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0013-2026Don't want to check this manually?
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