FDA Recalls Eliquis Due to Mislabeling

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Manufacturer Bristol-Myers Squibb has issued a voluntary recall of Eliquis, a commonly prescribed blood thinner. Eliquis can be used to reduce the risk of stroke due to atrial fibrillation, treat blood clots, prevent future blood clots, and decrease the risk of blood clots following surgery.

This is a class 1 recall, the most serious type of recall, which means that there is a situation where there is a reasonable probability that use of the recalled medication may cause serious adverse health consequences or death. For more information on the different types of recalls, see our overview here.

Who can recall a drug? 

A manufacturer can voluntarily recall their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recalls a particular medication.

In this case, the Bristol-Myers Squibb has voluntarily recalled Eliquis, with the knowledge of the FDA.

Why has Eliquis been recalled?

Eliquis was recalled on June 10th, 2017, due to a possible packaging error. It was found that a bottle labeled as Eliquis 5 mg contained 2.5 mg tablets, a lower strength. Receiving the wrong strength of Eliquis could potentially cause severe adverse effects like a blood clot, stroke, or death.

At this time, there have not been any reports of injuries or illnesses related to this issue.

Which Eliquis packages were affected?

This recall applies to one lot and one NDC (package) shipped nationwide February 2017. This recall affects the following:

Drug: Eliquis
Manufacturer: Bristol-Myers Squibb
Lot: HN0063 (Expiration date: 9/2019)
National Drug Codes (NDCs): 00003-0894-2

What do I do if I think I have a recalled package of Eliquis?

If you think you have the recalled Eliquis product, contact your doctor and call the Bristol-Myers Squibb Customer Information Center at 1-800-332-2056, Monday – Friday, from 8am-8pm. You can also visit the Bristol-Myers Squibb website here for more information.

Always inspect your medications, including all parts of the packaging and devices. If you ever notice your medication doesn’t look or smell right, contact the manufacturer or ask your pharmacist for more information. You can also notify the FDA’s MedWatch Reporting Program as they can conduct further necessary investigations. 

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