Drug product
Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Science Limited Bengaluru -562106 India Distributed by: Strides Pharma Inc., East Brunswick NJ 08816 NDC 64380-860-06
D-0001-2021
Product summary
- Firm
- Strides Inc.
- Event
- Event 86283
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,280 bottles
- Official record key
drug-enforcement:D-0001-2021
Official wording
Reason: Failed Dissolution Specifications
Code information: 7240675A; Exp. 12/31/2021
Distribution pattern: nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications