FDA recall D-0366-2025

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Class II · 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

Reason for recall

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

Distribution

Nationwide USA

Key facts

Status: Ongoing
Initiation date: 2025-04-14
Report date: 2025-04-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: La Vergne, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0366-2025