← FDA ENFORCEMENT
D-0221-2025Class 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
2025-02-12
Distribution
Nationwide in the USA
Firm state
TN
Product quantity
6997 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Dissolution Specifications.

Product description

Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61

Code / lot info

Lot# T05224; Exp. 02/2026

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.