FDA Alert on Epi-Pen Auto-Injectors 0.3 mg and 0.15 mg

EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may potentially have delayed injection or be prevented from properly injecting due to:

  1. Device failure from spontaneous activation caused by using sideways force to remove the blue safety release
  2. Device failure from inadvertent or spontaneous activation due to a raised blue safety release
  3. Difficulty removing the device from the carrier tube
  4. User errors

A very limited number of EpiPen devices also may have a blue safety release that is slightly raised. If the blue safety release is raised, the device may activate prematurely, which could potentially delay or prevent emergency treatment when needed.  

Additionally, in some cases EpiPen devices may not slide out of their carrier tube easily, or potentially at all, due to a slight deformation on the rim of the carrier tube. The carrier tube is the immediate package in which the auto-injector is contained. In some cases, the patient or caregiver may not be able to quickly remove the auto-injector from the carrier tube.  

Click here to read more.