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Generic drugmaker Mylan NV said on Friday that its manufacturing partner for EpiPen devices had expanded a recall of the life-saving allergy shot in the United States and other markets.
The announcement comes a week after Mylan said it had recalled about 81,000 EpiPen devices in countries outside the United States following two reports of the company's allergy treatment failing to work in emergencies.
The recall is being initiated in the United States and will extend to Europe, Asia, North and South America, Mylan said.
The recalled product was manufactured by Meridian Medical Technologies, a Pfizer Inc company, and distributed by Mylan between December 2015 and July 2016.
Mylan, which is the focus of multiple federal investigations, has come under fire for staggering price increases on the emergency shot in the United States.
Mylan has also been heavily criticized for classifying EpiPen as a generic rather than a branded product, which led to much smaller rebates from the company to state Medicaid programs.