Medication Monitor



Generic Name (Trade Name—Company)
Notes
June 15, 2017

Apixaban

(Eliquis—Bristol-Myers Squibb)
One lot of apixaban recalled after 2.5-mg tablets found in 5-mg bottle

Bristol-Myers Squibb is voluntarily recalling one lot (#HN0063) of apixaban 5-mg tablets to the consumer level in response to a customer report that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5-mg tablets. 

The lot was distributed nationwide in the United States and to wholesalers and retail pharmacies in February 2017.

Patients who are prescribed apixaban 5 mg for an irregular heartbeat and take an apixaban 2.5-mg tablet instead, particularly for a prolonged period, would have an increased probability of stroke, a moving blood clot, or death.

For patients with deep vein thrombosis, a blood clot in one of the deep veins, usually in the leg; or pulmonary embolism, a blood clot in the lung, 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.

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

There are distinct visible differences between the two tablet strengths, including colors, size, and markings that distinguish the 2.5-mg and 5-mg tablets and decrease the likelihood of an incorrect dose. The 2.5-mg presentation is a yellow, round, biconvex, film-coated tablet with “893” debossed on one side and “2½” on the other side. The 5-mg presentation is a pink, oval, biconvex, film-coated tablet with “894” debossed on one side and “5” on the other side.

Bristol-Myers Squibb has notified wholesalers and pharmacies to arrange for return and replacement of any recalled product.