Why it was recalled
Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain 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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide, Canada
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1595-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 12, 2014
- FDA report date
- Sep 24, 2014
- Quantity
- 50,724 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bristol-Meyers Squibb
Original FDA data
Every field from FDA enforcement report D-1595-2014, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 68276
- Address
- PO Box 4000
- 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
- Postal code
- 08543-4000
- Report date
- Sep 24, 2014
- Product type
- Drugs
- Recall number
- D-1595-2014
- Classification
- Class I
- Recalling firm
- Bristol-Meyers Squibb
- Product quantity
- 50,724 Vials
- Termination date
- May 29, 2015
- Reason for recall
- Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide, Canada
- Recall initiation date
- May 12, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 18, 2014