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COMPANY ANNOUNCEMENT

Update to Voluntary Recall of Eliquis® (apixaban) 5 mg Tablets (#HN0063) - Recall to retail/dispensing level only

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Update to Voluntary Recall of Eliquis® (apixaban) 5 mg Tablets (#HN0063) - Recall to retail/dispensing level only

Summary

Company Announcement Date:
June 17, 2017
FDA Publish Date:
December 01, 2018
Product Type:
Drugs
Reason for Announcement:
Company Name:
Bristol-Myers Squibb
Brand Name:
Brand Name(s)
Bristol-Myers Squibb
Product Description:
Product Description
Eliquis (apixaban) 5 mg Tablets

Company Announcement

On June 10, Bristol-Myers Squibb announced a voluntary recall of one lot (#HN0063) of Eliquisdisclaimer icon 5 mg tablets. 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 single customer complaint that a bottle labeled as Eliquis5 mg was found to contain Eliquis 2.5 mg tablets. No other lots are impacted by this recall.

This recall is to the retail/dispensing level and not to the consumer level. This recall is under way and is currently being executed. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Patients should not stop taking Eliquis without consulting with their physician

Please see Eliquis U.S. Full Prescribing Information, including Boxed WARNINGSdisclaimer icon.

For any customer or patient questions, please call:

General and Medical InquiriesBristol-Myers Squibb Customer Information Center
1-800-332-2056
Recall LogisticsFedEx Supply Chain
1-855-838-5785
Reimbursement/Replacement ProcessFedEx 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.

Additional Bristol-Myers Squibb Contacts:

Media: Ken Dominski, 609-252-5251, ken.dominski@bms.com
InvestorsTim Power 609-252-7509, timothy.power@bms.com

Previous related recall: Bristol-Myers Squibb Voluntarily Recalls One Lot of Eliquis (apixaban) 5 mg Tablets

Consumers

See table below
 

Media

Ken Dominski
ken.dominski@bms.com
609-252-5251