FDA Drug recall D-0006-2022
Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru…
- FDA Drug
- Class II
- terminated
- Published 2021-10-20
On 2021-10-20 the FDA classified a Class II recall of Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru… by Strides Pharma, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0006-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-27 |
| Published | 2021-10-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Strides Pharma |
| Distribution | US |
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.
Reason
Failed Dissolution Specifications
Identifiers
| ndc | 64380-860-06 |
|---|---|
| ndc | 64380-860-07 |
| ndc | 64380-860-08 |
| ndc | 64380-861-06 |
| ndc | 64380-861-07 |
| ndc | 64380-861-08 |
| code_info | Lot 7240840A, exp. 12/31/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0006-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.