Drug product

ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61

D-0366-2025

April 14, 2025

Class II

Product summary

Firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Event: Event 96679
Status: Ongoing
Classification: Class II
Quantity: 133 cartons
Official record key: drug-enforcement:D-0366-2025

Reason: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Code information: Lot#: N02114, Exp 12/31/2025

Distribution pattern: Nationwide USA

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

N-Nitroso-Desmethyl Chlorpromazine impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP deviations