COUMADIN FOR INJECTION — Class I drug recall D-1595-2014
Terminated recall by Bristol-Meyers Squibb, reported 2014-09-24, distributed nationwide. Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fibe
| Recall number | D-1595-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bristol-Meyers Squibb, Princeton, NJ, United States |
| Recall initiated | 2014-05-12 |
| Classified | 2014-09-18 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2015-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 50,724 vials |
| Reason classes | specification failure |
| NDC | 00590-0324-96 |
| Lot numbers | 00201125, 00201126, 00201127, 00201228, 00201229, 00201230, 06/15, 07/15, 09/14, 09/15, 11/14, 12/14 |
Product
COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vial Rx Only Distributed by Bristol Meyers Squibb Company, Princeton, NJ 08543 USA NDC 0590-0324-96
Reason for recall
Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1595-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.