Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

Mylan’s Voluntary EpiPen Recall Now Includes US

XTALKS VITALS NEWS

EpiPen

According to Mylan, the potentially defective auto-injectors may fail to activate in an emergency.

Share this!

April 4, 2017 | by Sarah Hand, M.Sc.

Meridian Medical, a Pfizer-owned company and Mylan’s manufacturing partner for the EpiPen, has expanded its recall of the medical device to include lots distributed in the US. The decision to expand the recall of the epinephrine auto-injectors was based on a meeting with the US Food and Drug Administration (FDA).

According to Mylan, the potentially defective auto-injectors may fail to activate in an emergency. Because the combination drug/device is used to treat patients experiencing a life-threatening allergic reaction, the consequences of having a nonfunctional auto-injector could be fatal.

In March, Mylan issued its first recall of specific batches of the EpiPen, which were distributed in New Zealand, Australia, Japan and Europe. The recall was initiated following reports that two EpiPens had failed to activate.

The initial recall affected a batch of approximately 80,000 medical devices. Now that Mylan and Meridian have expanded this voluntary recall to include 13 additional batches, the number of potentially affected devices is likely much higher.



The potentially defective auto-injectors include batches of both the EpiPen 2-Pak and EpiPen Jr 2-Pak, however no authorized generic versions are affected at this time. In addition to some batches in the US being affected by the recall, patients in other parts of North America, South America, Europe and Asia, may also be in possession of affected auto-injectors.

“Mylan is committed to replacing recalled devices at no cost and Mylan would like to reassure patients that there will be no additional replacement-related financial burden to them as a result of this recall,” said the Mylan press release on the expanded recall. “We are asking patients to keep their existing product until their replacement product can be secured.”

This recall is just the latest in a string of bad press for Mylan. Since 2016, the company has been facing scrutiny over its pricing practices for the EpiPen, which has risen in price to over $600 for a two-pack. Generic competitors – like Impax Pharmaceuticals’ Adrenaclick – are also increasingly looking to secure some of Mylan’s market share for the medical device.


Keywords:  EpiPen, Medical Device, Combination Product


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Food Companies are Looking for the Next Sriracha

October 19, 2017 - The Sriracha trend might be coming to an end and companies are looking for the next big hot sauce star to feature in their line-up.

Featured In: Food News


CFIA Recalling Mechanically Tenderized Steaks in Canada for E. coli

October 19, 2017 - The Canadian Food Inspection Agency posted a recall for mechanically tenderized steaks at the request of Vantage Foods Inc. on Tuesday.

Featured In: Food News


Study: Gender May Be Important When Matching Blood Transfusion Recipients to Donors

October 19, 2017 - According to a new study published in JAMA, gender and a history of pregnancy among female donors may have an impact on how well blood donors and recipients can be matched.

Featured In: Life Science News


LEAVE A COMMENT
 
  
THE XTALKS VITALS INDUSTRY BLOG

Five Reasons Why Toronto is Emerging as a Major Life Sciences Hub

REGISTER FOR THESE WEBINARS

Brexit – Separating Fact from Fiction


Evolving Best Practices for Working with Authors of Scientific Publications – Authorship and Beyond


Human Whole-Genome Sequencing in a New Era Defined by the Illumina® HiSeq X® and NovaSeq™ Platforms


Clinical Event Adjudication: Comprehensive and Efficient Dossier Review Using a Global On-Line Solution


Copyright © 2016-2017 Honeycomb Worldwide Inc.