Bristol-Myers Squibb Pulls One Lot of Apixaban Over Tablet Mix-up

Patrice Wendling

June 12, 2017

PRINCETON, NJ — One lot of apixaban (Eliquis, Bristol-Myers Squibb) 5-mg tablets is being voluntarily recalled after a consumer complained that a bottle labeled as Eliquis 5 mg actually contained 2.5-mg tablets, according to the company.

Patients who are prescribed Eliquis 5 mg for atrial fibrillation and "take a 2.5-mg tablet instead, particularly for a prolonged period, would have an increased probability of stroke, a moving blood clot, or death," Bristol-Myers Squibb said in a news release[1].

For patients with deep vein thrombosis and pulmonary embolism, it notes, "underdosing of the drug could lead to an increased risk of a growing or moving blood clot. Should that occur, it could be life-threatening or reversible depending on the severity and location of the blood clot."

No reports of related injuries or illnesses have been reported, according to the company.

The recall is being conducted with the US Food and Drug Administration.

The company notes the two tablets differ in strength but also in color, size, and markings, which should "decrease the likelihood of an incorrect dose."

The 2.5-mg tablet is round and yellow with "893" printed on one side and "2½" on the other side, whereas the 5 mg-tablet is pink and oval with "894" printed on one side and "5" on the flip side.

Eliquis 5- and 2.5-mg tablets

The recalled lot is HN0063, Exp 09/2019, NDC 0003-0894-2 and was distributed in February 2017 to wholesalers and retail pharmacies across the US. They have been notified to contact the drug maker to return and replace any recalled product.

Consumers with the recalled Eliquis are asked to contact their physician and Bristol-Myers Squibb at 800-332-2056 or via its website www.bms.com for more information.

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org, follow us on Twitter and Facebook.

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