Mylan Announces Expansion of EpiPen Recall to the US

On March 31, 2017 FDA announced that Meridian Medical Technologies is expanding a voluntarily recall to include 13 lots of Mylan’s EpiPen and EpiPen Junior (epinephrine injection) in the United States due to a potential defective part. Mylan said the defective part may cause activation failure in the autoinjectors. In a statement, Mylan said the recall will also extend to parts of Europe, Asia, and North and South America.

Earlier in March 2017, the company recalled 81,000 EpiPens in Australia, New Zealand, Europe, and Japan, Reuters reported. Mylan said it issued an expanded voluntary recall as a “precautionary measure out of an abundance of caution” after two failures were reported outside of the US.

Meridian Medical Technologies, a subsidiary of Pfizer, manufactured the recalled part for EpiPen. The recalled lots were distributed between Dec. 17, 2015 and July 1, 2016.

This is not the first time EpiPen has been in the news recently. Mylan faced intense scrutiny from government officials over its decision to increase the price of EpiPen more than 400% since it acquired the drug in 2007. The company also settled with the Department of Justice after it allegedly overcharged Medicaid for the life-saving treatment.

Source: Mylan, FDA