EpiPen recall expands to US after reports of device failure

EpiPen recall expands to US after reports of device failure

EpiPen recall expands to US after reports of device failure

It says EpiPens distributed between January and March of previous year and EpiPen Juniors from November 2015 to February 2016 were affected.

"The recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution", a Mylan spokesperson said in a statement.

The products involved in the recall are EpiPen auto-injectors with an expiry date of May 2017, and EpiPen Jr. auto-injectors with an expiry date of March 2017. 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. The defect occurs rarely and testing did not identify any product lots with a defect. (0.15 mg) 2-Pak Auto-Injectors that carry expiration dates between April and October. The company said more than 80,000 of the life-saving auto-injectors are covered by the recall worldwide, which was prompted by two reports of device failures.

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The FDA advises consumers to keep their devices until they have a replacement. Patients, customers and distributors are being notified and should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions.

We asked Mylan if there were any reports of patient harm and will update you accordingly. Mylan responded by initiating sales of a so-called authorized generic for $300, but now faces increased competition, as well.

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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