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Medication recall for one lot of Eliquis® (apixaban)

by
Optum Workers' Comp
| Jun 15, 2017

Bristol-Myers Squibb Company announced a consumer-level recall on one lot of Eliquis® (apixaban) 5 mg tablets were mislabeled due to a complaint from a customer who found Eliquis 2.5 mg tablets in their bottle that should have contained 5 mg tablets.

Eliquis is an anticoagulant (blood thinner) used to reduce the risk of stroke and blood clots in patients with nonvalvular atrial fibrillation, to prevent blood clots in the deep veins of the legs, known as deep vein thrombosis (DVT) and the lungs, known as pulmonary embolism (PE) in patients who have undergone hip or knee replacement surgery. Eliquis also treats blood clots and reduces the risk of recurrent DVTs and PEs following initial therapy. Although Eliquis is not commonly used in workers' compensation, it may be prescribed for select patients following hip or kne​e replacement surgery to prevent blood clots. 

The recalled lot was distributed to wholesalers and retail pharmacies in the United States in February 2017. If this product is mislabeled and contains a lower strength than what was prescribed, this can lead to an increased risk of stroke or a moving blood clot. Should that occur, it could be life-threatening or reversible depending on the severity and location of the blood clot. Patients should not stop taking Eliquis without first consulting their doctor. According to the recall notice, no reports of injuries or illnesses have been documented in relation to this issue.

There are distinct noticeable differences between the two tablet strengths including colors, size and markings distinguishing the 2.5 mg and 5 mg tablets and decrease the chance of an incorrect dose.

The 2.5 mg tablet is yellow, round, biconvex, and film-coated with “893” debossed on one side and “2½” on the other side. The 5 mg tablet is pink, oval, biconvex, and film-coated tablet with “894” debossed on one side and “5” on the other side.

The manufacturer has notified all wholesalers and retail pharmacies who purchased the product to arrange for return and replacement. Patients who are not sure if they have received medication from this lot number, or have questions should contact their doctor, health care provider or pharmacist if they have experienced any problems related to taking or using this medication.

For more information on this recall notice and contact information for Bristol-Myers Squibb, click here.

Product Name, Strength (Package Size)

NDC Number

Lot Number

Expiration Date

Eliquis (apixaban), 5 mg tablets
(60-count bottle)

0003-0894-21

HN0063

September 2019


Reference

U.S. Food and Drug Administration. Recalls, Market Withdrawals, and Safety Alerts. Bristol-Myers Squibb Voluntarily Recalls One Lot of Eliquis (apixaban) 5 mg Tablets. June 10, 2017. Available at https://www.fda.gov/Safety/Recalls/ucm563002.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed June 13, 2017. 




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