FDA Drug recall D-0294-2019
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 2018-12-19
On 2018-12-19 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 -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0294-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-10 |
| Published | 2018-12-19 |
| 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 -Two additional lots being recalled due to Out-of-Specification results 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 #: T700423, Exp 08/2019; T800310, Exp 03/2020 |
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-0294-2019%22
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