Drug recall D-0221-2025

Class II Ongoing reported Feb 12, 2025

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.

Lots and codes

Lot# T05224; Exp. 02/2026

Recall details

Recalling firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, La Vergne, TN
Quantity
6997 cartons
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
January 30, 2025

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