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Published: Mon, April 03, 2017
Economy | By Melissa Porter

FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

The lots of EpiPen and EpiPen Jr. that are affected were distributed between December 17, 2015, and July 1, 2016.

Mylan announced on March 31 a recall in the United States of 13 lots of EpiPen epinephrine auto-injectors over the risk that a small number of the devices might fail to activate because of a manufacturing defect. Meridian, which manufactures the EpiPen, had previously recalled a select amount of products across the world. EpiPens are used to treat severe allergic reactions.

They say there haven't been any confirmed cases involving lots of the injectors distributed in Canada. The kids version, EpiPen Jr., is also a part of the USA recall.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

EpiPens not included in the recall do not need to be replaced before their expiration dates, the FDA said. The Mylan adult version are sold with a yellow label while the EpiPen Jr.is sold with a green label.

There is a potential defect with a part in the injector making it hard to activate in an emergency, which could mean significant risks for people experiencing a life-threatening allergic reaction.

"The recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution", a Mylan spokesperson said in a statement.

Patients are being directed to Mylan.com/EpiPenRecall for replacement instructions, and the company is encouraging patients to keep their EpiPens handy even if they can't immediately get a replacement.

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