Global EpiPen Recall Now Includes U.S.

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By Robert Lowes
WebMD Health News

April 1, 2017 -- The U.S. has joined the list of countries covered by a voluntary recall of EpiPen auto-injectors for severe allergic reactions.

The recall was triggered by a defective part that may result in the device failing to inject a potentially life-saving dose of epinephrine, the FDA said Friday.

Mylan, the company that markets the device, announced last month that it was recalling one lot of roughly 80,000 EpiPens in Australia, Europe, Japan, and New Zealand. It reported two instances of the device failing to deliver its dose, although the two people were able to use backup EpiPens. Pressing the EpiPen into a person's thigh — where the pen is designed for use — causes a needle to penetrate skin and inject epinephrine into muscle. The defective part may require a person to use increased force to activate the needle, or it may prevent the EpiPen from working at all, according to Mylan.

In the United States, the recall applies to 13 lots of both EpiPen and EpiPen Jr. auto-injectors distributed between December 17, 2015, and July 1, 2016. Patients can receive another EpiPen or an authorized generic version at their pharmacy, Mylan said. In the meantime, they should continue to carry and use their current EpiPen until they acquire a replacement.

The affected lots are:

Product/DosageNDC NumberLot NumberExpiration Date
EpiPen Jr Auto-Injector, 0.15 mg49502-501-025GN767April 2017
EpiPen Jr Auto-Injector, 0.15 mg49502-501-025GN773April 2017
EpiPen Auto-Injector, 0.3 mg49502-500-025GM631April 2017
EpiPen Auto-Injector, 0.3 mg49502-500-025GM640May 2017
EpiPen Auto-Injector, 0.15 mg49502-501-026GN215September 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM082September 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM072September 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM081September 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM088October 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM199October 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM091October 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM198October 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM087October 2017

For further assistance, EpiPen users can contact Mylan at 800-796-9526 or email customer service at customer.service@mylan.com.

More information about the recall is available at the FDA website.

SOURCES: News release, FDA

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