COMPANY ANNOUNCEMENT
Update to Voluntary Recall of Eliquis® (apixaban) 5 mg Tablets (#HN0063) - Recall to retail/dispensing level only
This recall has been completed and FDA has terminated this recall.
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.
Read AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason DescriptionPotential Labeling Issue
- Company Name:
- Bristol-Myers Squibb
- Brand Name:
-
Brand Name(s)Bristol-Myers Squibb
- Product Description:
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Product DescriptionEliquis (apixaban) 5 mg Tablets
Company Announcement
On June 10, Bristol-Myers Squibb announced a voluntary recall of one lot (#HN0063) of Eliquis--]){kind=small}
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 WARNINGS.
For any customer or patient questions, please call:
| General and Medical Inquiries | Bristol-Myers Squibb Customer Information Center 1-800-332-2056 |
|---|---|
| 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.
- 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 pre-addressed form, or submit by fax to 1-800-FDA-0178.
Additional Bristol-Myers Squibb Contacts:
Media: Ken Dominski, 609-252-5251, ken.dominski@bms.com
Investors: Tim 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