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Bristol-Myers Squibb has announced a recall of 6 lots of the anticoagulant warfarin, sold as Coumadin for Injection in 5 mg single-use vials, in the US.
The company is recalling these lots after discovering visible particulate matter in unreleased samples of the drug.
The company said the safety risk to patients is likely low and is further mitigated by the product’s prescribing information, which advises that intravenous products be inspected visually before administration.
However, injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions, such as embolization. Allergic reactions to the foreign material could also occur.
To date, there have been no product complaints or adverse events reported to Bristol-Myers Squibb related to particulate matter in Coumadin for Injection.
Coumadin for Injection was discontinued in early April 2014. The oral formulation of Coumadin is not impacted by this recall.
Coumadin for Injection is packaged in cartons of six 5-mg single-use vials. The affected product includes the following 6 lots distributed to hospitals and pharmacies from November 2011 through January 2014:
Lot # Description NDC Expiration
201125 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Sept. 2014
201126 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Nov. 2014
201127 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Dec. 2014
201228 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 June 2015
201229 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 July 2015
201230 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Sept. 2015
Anyone with the aforementioned lots of Coumadin for Injection should stop using or distributing the product and contact Bristol-Myers Squibb’s recall vendor, GENCO, at 1-855-838-5784 to arrange for the return of remaining stock.
Customers with questions about the recall may contact the Bristol-Myers Squibb Customer Information Center at 1-800-332-2056.
Adverse reactions or quality problems associated with the use of this product can be reported to the FDA’s MedWatch Adverse Event Reporting Program. 
Bristol-Myers Squibb has announced a recall of 6 lots of the anticoagulant warfarin, sold as Coumadin for Injection in 5 mg single-use vials, in the US.
The company is recalling these lots after discovering visible particulate matter in unreleased samples of the drug.
The company said the safety risk to patients is likely low and is further mitigated by the product’s prescribing information, which advises that intravenous products be inspected visually before administration.
However, injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions, such as embolization. Allergic reactions to the foreign material could also occur.
To date, there have been no product complaints or adverse events reported to Bristol-Myers Squibb related to particulate matter in Coumadin for Injection.
Coumadin for Injection was discontinued in early April 2014. The oral formulation of Coumadin is not impacted by this recall.
Coumadin for Injection is packaged in cartons of six 5-mg single-use vials. The affected product includes the following 6 lots distributed to hospitals and pharmacies from November 2011 through January 2014:
Lot # Description NDC Expiration
201125 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Sept. 2014
201126 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Nov. 2014
201127 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Dec. 2014
201228 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 June 2015
201229 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 July 2015
201230 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Sept. 2015
Anyone with the aforementioned lots of Coumadin for Injection should stop using or distributing the product and contact Bristol-Myers Squibb’s recall vendor, GENCO, at 1-855-838-5784 to arrange for the return of remaining stock.
Customers with questions about the recall may contact the Bristol-Myers Squibb Customer Information Center at 1-800-332-2056.
Adverse reactions or quality problems associated with the use of this product can be reported to the FDA’s MedWatch Adverse Event Reporting Program.
Bristol-Myers Squibb has announced a recall of 6 lots of the anticoagulant warfarin, sold as Coumadin for Injection in 5 mg single-use vials, in the US.
The company is recalling these lots after discovering visible particulate matter in unreleased samples of the drug.
The company said the safety risk to patients is likely low and is further mitigated by the product’s prescribing information, which advises that intravenous products be inspected visually before administration.
However, injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions, such as embolization. Allergic reactions to the foreign material could also occur.
To date, there have been no product complaints or adverse events reported to Bristol-Myers Squibb related to particulate matter in Coumadin for Injection.
Coumadin for Injection was discontinued in early April 2014. The oral formulation of Coumadin is not impacted by this recall.
Coumadin for Injection is packaged in cartons of six 5-mg single-use vials. The affected product includes the following 6 lots distributed to hospitals and pharmacies from November 2011 through January 2014:
Lot # Description NDC Expiration
201125 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Sept. 2014
201126 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Nov. 2014
201127 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Dec. 2014
201228 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 June 2015
201229 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 July 2015
201230 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Sept. 2015
Anyone with the aforementioned lots of Coumadin for Injection should stop using or distributing the product and contact Bristol-Myers Squibb’s recall vendor, GENCO, at 1-855-838-5784 to arrange for the return of remaining stock.
Customers with questions about the recall may contact the Bristol-Myers Squibb Customer Information Center at 1-800-332-2056.
Adverse reactions or quality problems associated with the use of this product can be reported to the FDA’s MedWatch Adverse Event Reporting Program.