FDA Recall D-1595-2014

Bristol-Meyers Squibb · Princeton, NJ

Class I — life-threatening Terminated 382 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

Lot / code: 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

Quantity: 50,724 Vials

Reason for recall

Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials

Recall record

Recall number: D-1595-2014
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide, Canada
Recall initiated: 2014-05-12
Classified by FDA Center: 2014-09-18
FDA published: 2014-09-24
Terminated: 2015-05-29
Recalling firm: Bristol-Meyers Squibb
Firm location: Princeton, NJ

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