Recall of Mylan's EpiPen over possible defective part now expanded to US, other markets

Mylan announced that Pfizer's Meridian Medical Technologies unit, its manufacturing partner for EpiPen (epinephrine), has widened a voluntary recall of certain lots of the auto-injectors to now include additional batches distributed in the US and other markets in Europe, Asia, North America and South America. Last month, Mylan recalled 81 000 EpiPen devices in Australia, New Zealand, Europe and Japan following two reports of a potential defect in a component that could make the device difficult to activate in an emergency. 

Mylan noted that those two reports were related to a single lot. "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 stated, adding that additional lots have been included in the recall "as a precautionary measure out of an abundance of caution." According to the FDA, which issued a consumer alert on the matter, 13 identified lots, distributed between December 2015 and July 2016, are the "only EpiPen lots impacted by the US recall." 

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Mylan has come under intense scrutiny in the US in recent months over its price increases for EpiPen. The company has since introduced an authorised generic of the emergency allergy treatment at a 50-percent discount to its list price. Mylan said none of the recalled lots include the authorised generic version, which is also manufactured by Meridian Medical Technologies. 

Meanwhile, Mylan is also facing several investigations in the US, including a preliminary probe by the Federal Trade Commission, which is looking into whether the company tried to block generic competition for EpiPen. 

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