Bristol-Myers Squibb Eliquis Recall [US]


US FlagUS/Silver Spring: Bristol-Myers Squibb Eliquis Recall [US]Bristol-Myers Squibb recalls one batch/lots of Eliquis (apixaban) 5 mg Tablets due to suspected incorrect dosage packaging and consequential failure to protect against serious and life-changing cardiovascular events and/or Death, all serious health hazards. FDA: http://ht.ly/7WzT30cB77V

Direct link: https://www.fda.gov/Safety/Recalls/ucm563002.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Drugs are subject to this recall:

  • Eliquis 5 mg Tablets, distributed in one (1) known batch/lot, identified as HN0063, US nationwide to wholesalers and retail pharmacies in February 2017.

Please consult the photograph above for details of the drug’s design and retail presentation. One (1) additional image of the recalled Eliquis can be found on the Web site above.

==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, Bristol-Myers Squibb has recalled this one batch/lot of Eliquis after a customer complaint involving a bottle labeled as “Eliquis 5 mg” was, in fact, found to contain “Eliquis 2.5 mg” dosage tablets.

People who are prescribed Eliquis 5 mg for Atrial Fibrillation (a serious condition characterized by an irregular heartbeat) 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 people 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 this 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.

Please note: there are distinct visible differences between the two tablet strengths including colors, size and markings that distinguish the 2.5 mg from 5 mg tablets (see photos on the above Web site for differences) and decrease the likelihood of an incorrect dose. Specifically:

  • The 2.5 mg Eliquis tablet is a yellow, round, biconvex, film-coated tablet with the number “893” debossed on one side and the number “2-1/2” (indicating 2.5 mg) on the other side.
  • The 5 mg Eliquis tablet on the other hand, is pink, oval, biconvex, film-coated tablet with the code “894” debossed on one side and a single digit “5” (indicating a 5 mg dosage) on the other side. This tablet is illustrated above.

If you believe you have purchased or have in your possession any of the recalled drugs, contact your physician or pharmacist for a replacement.

==> Never stop taking your prescription medications, including Eliquis, without the knowledge and approval of your personal physician or other MD familiar with your medical history, current health status and other drugs, medications and supplements you may be consuming.

Please note: this recall has been updated for medical and healthcare professionals referencing additional drug details and FDA contact information. To see all notifications regarding this recall, please search for “Eliquis” using the Search Box at the top of this page.

If you have any questions about this recall, please contact Bristol-Myers Squibb Customer Information Center at 1-800-332-2056 from 8:00 AM to 8:00 PM Eastern Standard Time, Monday to Friday or on the Web at http://www.BMS.com for more information.

==> To see other recalls and notifications caused by suspected contaminated, adulterated or incorrectly dosed Drugs, please search for “drug” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 8807-2017
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

We welcome your feedback:
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E. & O. E.

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