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Class I: serious health riskTerminated

Bristol-myers Squibb EliquisTablets 5mg Recall

EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb Compan…

Bristol-myers Squibb Company · New Brunswick, NJ

Risk level
Class I
Reported by FDA
Jul 19, 2017
Recall ID
D-0959-2017
Check your lot numberHow we source this data

Summary

Bristol-myers Squibb recalled EliquisTablets 5mg starting Jun 5, 2017. The FDA classified it as Class I (serious health risk) and published enforcement report D-0959-2017 on Jul 19, 2017. 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. Status: Terminated.

Why it was 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.

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

Lot numbers, UPCs & expiration codes

Lot: HN0063, EXP. 09/2019

Where it was sold

Nationwide in the US

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0959-2017
Classification
Class I
Status
Terminated
Recall initiated
Jun 5, 2017
FDA report date
Jul 19, 2017
Quantity
48,180 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Bristol-myers Squibb Company

Original FDA data

Every field from FDA enforcement report D-0959-2017, exactly as published.

Show all FDA fields
City
New Brunswick
State
NJ
Status
Terminated
Country
United States
Event ID
77414
Address
1 Squibb Dr
Code information
Lot: HN0063, EXP. 09/2019
Postal code
08901-1588
Report date
Jul 19, 2017
Product type
Drugs
Recall number
D-0959-2017
Classification
Class I
Recalling firm
Bristol-myers Squibb Company
Product quantity
48,180 bottles
Termination date
Mar 15, 2022
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.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide in the US
Recall initiation date
Jun 5, 2017
Initial firm notification
E-Mail
Center classification date
Jul 11, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0959-2017, published Jul 19, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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