FDA recall D-0959-2017

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.

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2017-06-05

Report date

2017-07-19

Termination date

2022-03-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

New Brunswick, NJ, United States

Primary source

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