Published: Sun, April 02, 2017
Finance | By Laverne Griffith

Mylan EpiPen recalled in US, abroad

Mylan EpiPen recalled in US, abroad

"This recall is due to the potential that these devices may contain a defective part that may result in the devices' failure to activate", the FDA said in a news release.

Mylan said in a statement that the recall will expand to Europe, Asia and North and South America.

Mylan NV said it was expanding a recall of its EpiPen allergy injection to the United States, 10 days after it issued a recall of more than 80,000 devices around the world. EpiPens are used to counteract severe allergic reactions.

EpiPens distributed in the United States are now among the tens of thousands being recalled because they don't work.

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Mylan said both reported failures included devices, manufactured between December 2015 and July 2016, that were already included in the original recall.

Consumers with questions regarding this recall can contact Pfizer Medical Information at 1-800-463-6001 between 9:00 a.m. and 5:00 p.m. EST. The recall does not affect the authorized generic version of the EpiPen. Mylan is replacing any devices on the recall list for free.

In Canada, the recall impacts one lot (5GU763) of the 0.3 mg strength of EpiPen Auto-Injector expiring in May 2017 and one lot (5GR765) of the 0.15 mg strength of EpiPen Jr Auto-Injector expiring in March 2017.

About 15 million people have food allergies in the USA, and allergic reactions account for about 200,000 emergency room visits per year, according to Food Allergy Research & Education.

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