Mylan says EpiPen manufacturing partner to expand device recall

Matthew Orr  STAT
Matthew Orr STAT
Author

02 April, 2017

EpiPens distributed in the United States are now among the tens of thousands being recalled because they don't work.

In a statement, Mylan pointed to "two previously disclosed reports" outside of the U.S. in which the device failed to activate due to a "potential defect" in a component supplied by Meridian Medical Technologies, a Pfizer unit that makes EpiPen. The FDA said the number of reported failures is small, but the lots are being recalled because failure to activate and treat a severe allergic reaction is a life-threatening risk.

Mylan called the defect "extremely rare", and is recalling 13 lots of the pens. The recall doesn't include the authorized generic version of the EpiPen that Mylan introduced in December.

Mylan says: "Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability".

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Mylan didn't immediately respond to a question about how many devices are affected by the recall. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty, according to the FDA's press release dated March 31, 2017.

Rather than discard the recalled EpiPens, Mylan is suggesting that patients who have one of the devices on the above list to hold onto their injector until they have secured a replacement.

To return your product please contact Stericycle at 877-650-3494.

About 15 million people have food allergies in the USA, and allergic reactions account for about 200,000 emergency room visits per year, according to Food Allergy Research & Education.


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