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Defect Prompts Mylan to Recall Some Epipens
Rare cases of 'failure to activate' during potentially fatal allergic reactions spurred the action, company says

By E. J. Mundell

MONDAY, April 3, 2017 (HealthDay News) -- Mylan, the maker of the Epipen, says it is recalling "select lots" of the device used to treat dangerous allergic reactions due to a defect that might render it "difficult to activate in an emergency."

The pen-like device is used to help counteract potentially fatal reactions (anaphylactic shock) in people with severe allergies. Epipen gives users an injection of epinephrine to help curb the reaction.

Mylan said it consulted with the U.S. Food and Drug Administration and "Meridian Medical Technologies, a Pfizer company and Mylan's manufacturing partner for EpiPen Auto-Injector, and has expanded a voluntary recall of select lots" of Epipen and Epipen Jr.

Mylan said the recall was prompted by two reports -- both occurring outside the United States -- of the products' "failure to activate" because of a potential defect in a component part.

Failure to activate could "have significant health consequences for a patient experiencing a life-threatening allergic reaction," Mylan said in a news release.

"The incidence of the defect is extremely rare, and testing and analysis across the potentially impacted lots has not identified any units with a defect," the company added. However, the recall has been expanded out of an "abundance of caution," Mylan said.

"The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector," Mylan said. "None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies."

Consumers can get a detailed list of the Epipen and Epipen Jr. lots under recall by going to the company's website at www.mylan.com. They can also call Mylan at 877-796-9526.

Consumers can receive a replacement of the recalled devices for free by calling 877-650-3494.

"It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device," the company said.

Epipen -- long the standard device for emergency use in cases of anaphylactic shock -- has been the subject of controversy over the past year, ever since Mylan hiked the price of an Epipen two-pack to more than $600.

The company introduced a generic two-pack product in December. It costs $300.

More information

There's more on anaphylactic shock at the American College of Asthma, Allergy & Immunology.

SOURCE: Mylan, news releases, April 1, 2017 and March 31, 2017

Copyright © 2017 HealthDay. All rights reserved. URL:http://consumer.healthday.com/Article.asp?AID=721241

Resources from HONselect: HONselect is the HON's medical search engine. It retrieves scientific articles, images, conferences and web sites on the selected subject.
Hypersensitivity
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The list of medical terms above are retrieved automatically from the article.

Disclaimer: The text presented on this page is not a substitute for professional medical advice. It is for your information only and may not represent your true individual medical situation. Do not hesitate to consult your healthcare provider if you have any questions or concerns. Do not use this information to diagnose or treat a health problem or disease without consulting a qualified healthcare professional.
Be advised that HealthDay articles are derived from various sources and may not reflect your own country regulations. The Health On the Net Foundation does not endorse opinions, products, or services that may appear in HealthDay articles.


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