Bristol-Myers Squibb Recalls Coumadin for Injection Due to Particulate Matter
Bristol-Myers Squibb is recalling Coumadin for Injection vials because metallic-like and cellulose fiber particles were found in retained samples.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a score of 5 per the rubric.
Plain-English summary
Bristol-Myers Squibb is recalling 50,724 vials of COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vial). The recall covers specific lots with expiration dates ranging from September 2014 to September 2015. The product was distributed nationwide and in Canada.
The recall was initiated because particulate matter, identified as metallic-like and non-metallic cellulose fiber particles, was found in retained vials. The U.S. Food and Drug Administration has classified this as a Class I recall.
Healthcare providers and patients should stop using the affected vials and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- 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
- Manufacturer
- Bristol-Meyers Squibb
- Category
- Drug — Anticoagulant
- Hazard
- Affected units
- 50,724
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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
Distribution
Distributed nationwide across the United States.
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