FDA-Drug2017-07-19Class I

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

Bristol-myers Squibb Company
Hazard

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.

Sold states
Nationwide in the US
Affected count
48,180 bottles
Manufactured in
1 Squibb Dr, New Brunswick, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0959-2017

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