Drug product
Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-861-08
D-1029-2020
Product summary
- Event
- Event 84968
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2576 bottles
- Official record key
drug-enforcement:D-1029-2020
Official wording
Reason: Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Code information: Lot #: 7238958A, 7238257A, Exp 7/31/2021; 7239404A, Exp 9/30/2021
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.