Drug 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
D-0959-2017
Product summary
- Event
- Event 77414
- Status
- Terminated
- Classification
- Class I
- Quantity
- 48,180 bottles
- Official record key
drug-enforcement:D-0959-2017
Official wording
Reason: 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.
Code information: Lot: HN0063, EXP. 09/2019
Distribution pattern: Nationwide in the US
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up