Drug product
Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.
D-0006-2022
Product summary
- Event
- Event 88759
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1813 bottles
- Official record key
drug-enforcement:D-0006-2022
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot 7240840A, exp. 12/31/2021
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications