Recalls / Class I
Class ID-0959-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- Lot: HN0063, EXP. 09/2019
Why it was recalled
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.
Recalling firm
- Firm
- Bristol-myers Squibb Company
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1 Squibb Dr, New Brunswick, New Jersey 08901-1588
Distribution
- Quantity
- 48,180 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2017-06-05
- FDA classified
- 2017-07-11
- Posted by FDA
- 2017-07-19
- Terminated
- 2022-03-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0959-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.