Recall of anti-allergy medicine EpiPen expands to the U.S.

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The recall is due to the potential that these devices may contain a defective part that may result in the devices' failure to activate.

Mylan, the company that manufactures them, issued a recall of over 80,000 EpiPens in Norway, Denmark, Finland, Ireland, Australia, New Zealand, and Japan in late March.

The recall affects 13 lots of EpiPen and EpiPen Jr. devices distributed between December 17, 2015, and July 1, 2016.

The Food and Drug Administration is alerting consumers to a voluntary recall of Mylan's EpiPen and EpiPen Jr.

The injection is used to counteract unsafe allergic reactions, such as those from bee stings or food allergies.

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EpiPen is made by a company called Mylan, which you may recognize from recent controversy over its significant price hikes over the course of last few years. This particular lot was not distributed in the U.S. The recall was initiated after Mylan received two confirmed reports of the devices failing to activate due to a possible defect. After Mylan bought the product in 2007 the drug company raised prices nearly 600 percent over the course of the next decade.

Mylan didn't immediately respond to a question about how many devices are affected by the recall.

Consumers should keep and use their EpiPen until they have a replacement.

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.

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