Bristol-Meyers Squibb
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
Status:Ongoing
City:Princeton
State:NJ
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:Nationwide, Canada
Classification:Class I
Product 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 Initiation Date:20140512
Report Date:20140924

Coumadin

Coumadin

Coumadin Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

COUMADIN® is indicated for:

  • Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE).
  • Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement.
  • Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.

Limitations of Use

COUMADIN has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.

History

There is currently no drug history available for this drug.

Other Information

COUMADIN (warfarin sodium) is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is C19H15NaO4, and its structural formula is represented by the following:

warfarin sodium chemical structure

Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether.

COUMADIN tablets for oral use also contain:

All strengths:Lactose, starch, and magnesium stearate
1 mg:D&C Red No. 6 Barium Lake
2 mg:FD&C Blue No. 2 Aluminum Lake and
FD&C Red No. 40 Aluminum Lake
2-1/2 mg:D&C Yellow No. 10 Aluminum Lake and
FD&C Blue No. 1 Aluminum Lake
3 mg:FD&C Yellow No. 6 Aluminum Lake,
FD&C Blue No. 2 Aluminum Lake, and
FD&C Red No. 40 Aluminum Lake
4 mg:FD&C Blue No. 1 Aluminum Lake
5 mg:FD&C Yellow No. 6 Aluminum Lake
6 mg:FD&C Yellow No. 6 Aluminum Lake and
FD&C Blue No. 1 Aluminum Lake
7-1/2 mg:D&C Yellow No. 10 Aluminum Lake and
FD&C Yellow No. 6 Aluminum Lake
10 mg:Dye-free

COUMADIN for injection for intravenous use is supplied as a sterile, lyophilized powder, which, after reconstitution with 2.7 mL Sterile Water for Injection, contains:

Warfarin sodium2 mg per mL
Sodium phosphate, dibasic, heptahydrate4.98 mg per mL
Sodium phosphate, monobasic, monohydrate0.194 mg per mL
Sodium chloride0.1 mg per mL
Mannitol38.0 mg per mL
Sodium hydroxide, as needed for pH adjustment to 8.1 to 8.3

Coumadin Manufacturers


  • A-s Medication Solutions Llc
    Coumadin (Warfarin Sodium) Tablet [A-s Medication Solutions Llc]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Coumadin (Warfarin Sodium) Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Aphena Pharma Solutions – Tennessee, Inc.
    Coumadin (Warfarin Sodium) Tablet [Aphena Pharma Solutions – Tennessee, Inc.]
  • Aphena Pharma Solutions – Tennessee, Inc.
    Coumadin (Warfarin Sodium) Tablet [Aphena Pharma Solutions – Tennessee, Inc.]
  • Bristol-myers Squibb Holdings Pharma, Ltd. Liability Company
    Coumadin (Warfarin Sodium) Injection, Powder, Lyophilized, For Solution [Bristol-myers Squibb Holdings Pharma, Ltd. Liability Company]
  • Remedyrepack Inc.
    Coumadin (Warfarin Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Coumadin (Warfarin Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Coumadin (Warfarin Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Coumadin (Warfarin Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Coumadin (Warfarin Sodium) Tablet [Remedyrepack Inc. ]
  • Physicians Total Care, Inc.
    Coumadin (Warfarin Sodium) Tablet [Physicians Total Care, Inc.]
  • Remedyrepack Inc.
    Coumadin (Warfarin Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Coumadin (Warfarin Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Coumadin (Warfarin Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Coumadin (Warfarin Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Coumadin (Warfarin Sodium) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Coumadin (Warfarin Sodium) Tablet [Remedyrepack Inc. ]
  • A-s Medication Solutions Llc
    Coumadin (Warfarin Sodium) Tablet [A-s Medication Solutions Llc]
  • Bristol-myers Squibb Pharma Company
    Coumadin (Warfarin Sodium) Tablet [Bristol-myers Squibb Pharma Company]
  • Cardinal Health
    Coumadin (Warfarin Sodium) Tablet [Cardinal Health]

Login To Your Free Account