The voluntary recall comes just 10 days after Mylan issued a recall of more than 80,000 devices from around the world.
“This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component,” Mylan said in a statement.
“The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). “
Mylan said it’s extending the lots included in the recall as a precautionary measure. The devices, manufactured by Meridian Medical Technologies, were made between December 2015 and July 2016.
Mylan was called out in August 2016 for raising the price of the EpiPen to $US608.61 from $US93.88 over the past decade. It caught the nation’s attention because parents were refilling their kids’ prescriptions, and some found that they were on the hook for hundreds of dollars for the device. The recall doesn’t include the authorised generic version of the EpiPen that Mylan introduced in December.
Mylan said in a release that the EpiPens that are recalled will be replaced at no cost.
Here are the lots impacted by the recall:
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