D-0959-2017 Class I Terminated
FDA drug recall D-0959-2017 was initiated by Bristol-Myers Squibb Company on Jun 5, 2017 and is designated Class I. 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. The recall status is terminated (terminated Mar 15, 2022). Affected quantity: 48,180 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 19, 2017
- Initiation Date
- Jun 5, 2017
- Termination Date
- Mar 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,180 bottles
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.
Distribution Pattern
Nationwide in the US
Code Information
Lot: HN0063, EXP. 09/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0959-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026