← FDA ENFORCEMENT
D-0366-2025Class II

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Recalling firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Product type
Drug
Status
Ongoing
Report date
2025-04-23
Distribution
Nationwide USA
Firm state
TN
Product quantity
133 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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

Code / lot info

Lot#: N02114, Exp 12/31/2025

Other recalls SPEQ maps to Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc
See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.