EpiPen manufacturer expands recall to U.S. due to potential failure to activate

Credit: DaytonDailyNews

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The Biggest Product Recalls in US History

Credit: DaytonDailyNews

The company behind the EpiPen, a life-saving drug-delivery device for severe allergic reactions, has expanded a recall of the device. It previously recalled some sets of the auto-injector abroad, but it now includes some in the United States and extended to markets in Europe amd Asia, as well as North and South America.

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Pharmaceutical company Mylan previously said in a March 20 recall notice that one batch of EpiPens might not work properly. The batch went to Australia, New Zealand, Europe and Japan. The company voluntarily recalled those.

Mylan said that it got two reports worldwide of EpiPens to activate out of a batch of 80,000 devices. The issue came from a defective part, the company said.

Now, the company has recalled what it says are select lots of EpiPen and EpiPen Jr, as well as additional auto-injectors distributed in the United States,

Mylan said that the impacted items include 0.3 mg and 0.15 mg strengths of the auto-injector but that none of the recalled items include the generic auto-injector manufactured by Meridian Medical Technologies, Mylan’s manufacturing partner for the device.

Mylan came under fire recently for raising the price of the EpiPen to $600. The cost amounts to a 400 percent increase in price between 2007, when Mylan acquired the devices, and 2016.

The full list of impacted lots in the United States are at the Mylan website.

The Cox Media Group National Content Desk contributed to this report.