Over 80,000 EpiPens have been recalled in several countries due to a faulty mechanism, the company announced on Monday.
According to Mylan, the company that manufactures EpiPens, they have been recalled because the devices may have a defective part that "may result in the device failing to activate or requiring increased force to activate."
The devices affected by the recall were distributed in Australia, New Zealand, Japan, and a variety of European countries, but not in the United States, a Mylan spokesperson told STAT News.
The recall announcement states that there have been two reported incidents in which the EpiPens failed to work, but did not specify as to whether or not anyone was injured as a result.
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EpiPens are auto-injectors that contain doses of epinephrine in cases of severe, often life-threatening allergies that can send some into anaphylactic shock. For those who suffer from severe allergic reactions, an EpiPen can mean the difference between life and death.
Last year, EpiPens underwent a huge price hike, sparking outrage and even the release of a cheaper alternative from a competitor.
According to the recall announcement, the recalled EpiPens expire in April. Anyone who has an EpiPen affected by the recall can trade theirs in for a new one, free of charge — though patients are encouraged to keep their current EpiPen until they get a replacement.
For more information about the affected EpiPens, take a look at Mylan's statement.