PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: July 19, 2017 Initiated: June 5, 2017 #D-0959-2017

Product Description

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.

Details

Units Affected
48,180 bottles
Distribution
Nationwide in the US
Location
New Brunswick, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Bristol-myers Squibb Company. Units affected: 48,180 bottles.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 19, 2017. Severity: Critical. Recall number: D-0959-2017.