D-0006-2022 Class II Terminated
FDA drug recall D-0006-2022 was initiated by Strides Pharma Inc. on Sep 27, 2021 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated Oct 26, 2022). Affected quantity: 1813 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 20, 2021
- Initiation Date
- Sep 27, 2021
- Termination Date
- Oct 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0006-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026