Class II
Ongoing
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
This recall is currently active, issued February 12, 2025. It was issued by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories.
- Recall Initiated
- January 30, 2025
- Posted
- February 12, 2025
- Recall Number
- D-0221-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6997 cartons
- Firm Location
- La Vergne, TN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications.
Distribution
Nationwide in the USA
Lot / Code Info
Lot# T05224; Exp. 02/2026
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