Recall D-0221-2025

US Class II Ongoing · initiated 2025-01-30

Recalling firm

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, TN

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

Reason for recall

Failed Dissolution Specifications.

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