Bristol-Myers Squibb Company (NYSE: BMY) is voluntarily recalling one lot (#HN0063) of Eliquis 5 mg tablets to the consumer level. This lot was distributed nationwide in the U.S. to wholesalers and retail pharmacies in February 2017. Bristol-Myers Squibb is taking this precautionary measure based on a customer complaint that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets.

Image/FDA
Eliquis 5 mg Image/FDA

Patients should not stop taking Eliquis without consulting with their physician. Patients who are prescribed Eliquis 5 mg for an irregular heartbeat (atrial fibrillation) and take an Eliquis 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 (DVT), a blood clot in one of the deep veins usually in the leg, and Pulmonary Embolism (PE), 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.

Eliquis tablets are indicated to reduce the risk of stroke and blood clots in people who have atrial fibrillation; it also treats blood clots in the veins of your legs or lungs as well as reduces the risk of forming a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery. Eliquis 5 mg tablets are packaged in 60-count bottles, lot HN0063, Exp 09/2019, NDC 0003-0894-21. The recalled lot was distributed Nationwide in the U.S. to wholesalers and retail pharmacies in February 2017.

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.

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Bristol-Myers Squibb has notified wholesalers and pharmacies to arrange for return and replacement of any recalled product. Consumers that have product being recalled (Lot #HN0063) should contact their physician and call the Bristol-Myers Squibb Customer Information Center at 1-800-332-2056, Monday – Friday, from 8 AM – 8 PM EST or visit BMS.com for more information.

Eliquis 2.5/FDA
Eliquis 2.5 mg/FDA