FDARecalled Oct 15, 2025 · #D-0013-2026
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-...
Hazard
Class II — temporary health risk
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CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Classification: Class II Distribution: Nationwide
Product details
- Product
- 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
- Type
- Drugs
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Model numbers
- —
- UPCs
- —