FDA Drug recall D-0283-2019
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srika…
- FDA Drug
- Class II
- terminated
- Published 2018-11-28
On 2018-11-28 the FDA classified a Class II recall of Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srika… by Dr Reddy S Laboratories, citing failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0283-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-07 |
| Published | 2018-11-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31
Reason
Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Identifiers
| ndc | 55111-671-30 |
|---|---|
| ndc | 55111-671-90 |
| ndc | 55111-671-01 |
| ndc | 55111-671-05 |
| ndc | 55111-671-48 |
| ndc | 55111-671-79 |
| ndc | 55111-671-81 |
| ndc | 55111-671-06 |
| ndc | 55111-671-31 |
| ndc | 55111-671-78 |
| code_info | Lot #: T600530, Exp 11/18 |
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-0283-2019%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.