Drug 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
D-0221-2025
Product summary
- Event
- Event 96201
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6997 cartons
- Official record key
drug-enforcement:D-0221-2025
Official wording
Reason: Failed Dissolution Specifications.
Code information: Lot# T05224; Exp. 02/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications