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Recalls Market Withdrawals Safety Alerts _ Bristol-Myers Squibb recalls on lot of Eliquis 5mg tablets


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.
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,
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.
Patient safety is our first priority. 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. Please see Eliquis U.S. Full Prescribing Information, including Boxed
Warnings.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Adverse reactions 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. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm. Regular
Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-
1088 to request a reporting form, then complete and return to the address on the preaddressed
form, or submit by fax to 1-800-FDA-0178.

Contact:

Bristol-Myers Squibb: Customer Information Center 800-332-2056