Bristol-Myers Squibb Eliquis Recall Update [US]


US FlagUS/Silver Spring: Bristol-Myers Squibb Eliquis Recall [US]Bristol-Myers Squibb updates its existing recall for one (1) 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/CpHA30cGw9G

Direct link: https://www.fda.gov/Safety/Recalls/ucm563547.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 original FDA recall site available here: https://www.fda.gov/Safety/Recalls/ucm563002.htm.

==> 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 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.

This update to Bristol-Myers Squibb’s existing Eliquis recall is aimed at the retail/dispensing level and not at the consumer level.

==> Please remind your patients not to stop taking Eliquis (or other prescription medication) without consulting with their personal physician.

You can see important information, including Boxed Warnings, regarding Eliquis here (viewable as a PDF): http://packageinserts.bms.com/pi/pi_eliquis.pdf

For any customer or patient questions, please call the following contact points, as applicable:

General and Medical Inquiries Bristol-Myers Squibb Customer Information Center
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.
Recall Logistics FedEx Supply Chain
1-855-838-5785
Reimbursement/Replacement Process FedEx Supply Chain
1-855-838-5785

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax, as follows:

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More information about this recall:
Recalls Direct RIN: 8824-2017
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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