D-0006-2022 Class II Terminated
FDA drug recall D-0006-2022 was initiated by Strides Pharma Inc. on September 27, 2021 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated October 26, 2022). Affected quantity: 1813 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 20, 2021
- Initiation Date
- September 27, 2021
- Termination Date
- October 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1813 bottles
Product Description
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.
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide
Code Information
Lot 7240840A, exp. 12/31/2021