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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters),

Recalled February 12, 2025 · FDA recall D-0221-2025 · The Harvard Drug Group LLC

Hazard
Failed Dissolution Specifications. · FDA Class II
Units
6997 cartons
Sold at
Nationwide in the USA

Description

Failed Dissolution Specifications.

Product
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
Manufacturer(s)
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov