D-1595-2014 Class I Terminated

Recalled by Bristol-Meyers Squibb — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
September 24, 2014
Initiation Date
May 12, 2014
Termination Date
May 29, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
50,724 Vials

Product Description

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

Distribution Pattern

Nationwide, Canada

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