FDA Drug recall D-0001-2021
Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Scien…
- FDA Drug
- Class II
- terminated
- Published 2020-10-07
On 2020-10-07 the FDA classified a Class II recall of Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Scien… by Strides, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0001-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-24 |
| Published | 2020-10-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Strides |
| Distribution | US |
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
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 | 7240675A; 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-0001-2021%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.