FDA Recall D-0959-2017
Bristol-myers Squibb Company · New Brunswick, NJ
Class I — life-threatening Terminated 1744 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA and Pfizer Inc. New York, NY 10017 USA, NDC 0003-0894-21
Reason for recall
Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets.
Recall record
- Recall number
D-0959-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide in the US
- Recall initiated
- 2017-06-05
- Classified by FDA Center
- 2017-07-11
- FDA published
- 2017-07-19
- Terminated
- 2022-03-15
- Recalling firm
- Bristol-myers Squibb Company
- Firm location
- New Brunswick, NJ