Drug 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
D-1595-2014
Product summary
- Event
- Event 68276
- Status
- Terminated
- Classification
- Class I
- Quantity
- 50,724 Vials
- Official record key
drug-enforcement:D-1595-2014
Official wording
Reason: Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials
Code information: Lot 00201125, Exp. 09/14; 00201126 Exp.11/14; 00201127, Exp.12/14; 00201228 Exp.06/15; 00201229 Exp. 07/15; 00201230, Exp. 09/15
Distribution pattern: Nationwide, Canada
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter