EpiPen, EpiPen Jr. Subject of Voluntary Recall

Pharmaceutical company, Mylan, distributor of the EpiPen and EpiPen Jr., issued a voluntary recall of more than 80,000 EpiPens in Australia, New Zealand, Japan and other nations late in March 2017; on March 31, the company added a recall of its EpiPen and EpiPen Jr. in the United States.

The first recall of the anti-allergy and potentially life-saving EpiPen came in the third week of March and involved a total of 81,000 EpiPens in Australia, Denmark, Finland, Ireland, Japan, New Zealand and Norway. On March 31, 2017, as announced by the U.S. Food and Drug Administration, an update to the EpiPen recall included the United States, Asia, Europe, and both North and South America.

The EpiPen Jr. was included in the updated recall, with concerns over both it and the EpiPen’s ability to work properly in an emergency due to a defective part included in its manufacturing by Mylan’s manufacturing partner, Merdian Medical Technologies, a Pfizer Inc. company. The EpiPens and EpiPens Jr. involved in the recall were distributed between December 2015 through July 2016.

In the United States, there are 13 lots of EpiPens and EpiPens Jr. that are subject to the recall:

Product/Dosage

NDC Number

Lot Number

Expiration 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 Jr 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

To date, only two of the epinephrine auto-injector devices have failed, something Mylan referred to as “extremely rare,” although even if rare, could be life-threatening. Consumers who have EpiPens or the EpiPen Jr. listed in one of these 13 recall lots are encouraged by the FDA to keep and use their current EpiPens is need be until a replacement is issued. For a replacement of a recalled device, call 800-796-9526 or contact Mylan customer service at [email protected]


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