Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx ...
FDA Recall #D-0013-2026 — Class II — September 12, 2025
Product Description
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
Reason for Recall
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — La Vergne, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1394 blister packs
Distribution
Nationwide
Code Information
Lots N01928, Exp. Date, 09/30/2025, N02008, Exp. Date, 03/21/2026 & N02071, Exp. Date 02/28/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated