Drug product
Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617
D-0011-2026
Product summary
- Event
- Event 97584
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 506 blister packs
- Official record key
drug-enforcement:D-0011-2026
Official wording
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Code information: Lots N02009 & N02026, exp. date 02/28/2026
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations