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),…

Recall date

January 30, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0221-2025

FDA classification

Class II

Brand / firm

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Sold / distributed

Nationwide in the USA

Why it was recalled

Failed Dissolution Specifications.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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