Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

Bristol-Myers Squibb Recalls Lot of Eliquis Due to Dosage Mislabeling

By FDA MedWatch | June 14, 2017

Bristol-Myers Squibb voluntarily recalls one lot of Eliquis (apixaban) 5 mg tablets.

Bristol-Myers Squibb Company 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, size and markings that distinguish the 2.5 mg and 5 mg tablets (see photos) 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 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. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.

(Source: FDA)

Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!

Related Articles Read More >

Taro Pharmaceuticals announces Type I recall of Taro-zoledronic acid injection
Fresenius Kabi
Fresenius Kabi plans to add 2D barcodes to its pharmaceutical portfolio
analyzing medical sample
Expert answers to nitrosamine impurity questions
FDA logo
FDA warns four companies over selling honey tainted with prescription drugs

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards