03 April, 2017
The recall includes 13 lots of both EpiPen and EpiPen Junior distributed between December 17, 2015 through July 1, 2016. The U.S. recall was initiated after two previously disclosed reports outside the U.S. of devices that failed to activate due to a defect in a supplier component.
The EpiPen 0.3 mg has an expiry date of May 2017 and lot number 5GU763.
EpiPens administer doses of epinephrine to patients with anaphylaxis - a serious allergic reaction that can be fatal if not treated immediately.
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The FDA is advising consumers to keep and use their current EpiPens if needed until they get a replacement.
Mylan has already issued a recall on several lots previous to Friday's announcement, but said they expanded it out of an abundance of caution.
In a statement, the company warns that the potential defect could make it more hard to activate the device in an emergency situation-which, in general, is the most appropriate time to use the device.
The recalled items will be replaced at no cost. The company is, however, advising that due to the nature of the need, those seeking to replace their potentially faulty auto-injector devices should still keep them handy, even if they can not get a replacement.