D-0012-2026 Class II Ongoing
FDA drug recall D-0012-2026 was initiated by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories on September 12, 2025 and is designated Class II. Reason for recall: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit The recall status is ongoing. Affected quantity: 866 blister packs.
Recall Details
- Product Type
- Drugs
- Report Date
- October 15, 2025
- Initiation Date
- September 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 866 blister packs
Product Description
Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614
Reason for Recall
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Distribution Pattern
Nationwide
Code Information
Lots N01920, Exp. Date, 12/31/2025, N02023, Exp. Date, 02/28/2026 & N02202, Exp. Date, 06/30/2026