Some EpiPens are being recalled because they can malfunction during use, a problem that could cause serious injuries or death, the Food and Drug Administration (FDA) warned in a Safety Communication. EpiPens are emergency injectors used to treat severe allergic reactions in both adults and children.

The recall, issued this week by EpiPen manufacturers Pfizer and Mylan, affects EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, as well as the authorized generic versions, because they may potentially have delayed injection or be prevented from properly injecting. The issue stem from one of a number of factors:

  • Device failure from spontaneous activation caused by using sideways force to remove the blue safety release;
  • Device failure from inadvertent or spontaneous activation due to a raised blue safety release;
  • Difficulty removing the device from the carrier tube;
  • Or, user errors.

People with severe allergies often keep EpiPens on them at all times in order to receive lifesaving injections of epinephrine in the event of a life-threatening allergic reaction or anaphylaxis. Mylan and Pfizer told patients top keep two EpiPens on them at all times – instead of just one – in the event one of the auto-injectors malfunctions.

Mylan has been scrutinized for increasing the price of EpiPen from about $60 for a pair of auto-injectors in 2007 to $600 a pair in 2016. Mylan refused to reduce the price, instead offering its own generic version at half the cost.

Pfizer also manufacturers EpiPens, but quality control issues at its manufacturing plants have resulted in shortages at times.

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