FDA Warns of Possible Failure of EpiPen Injectors
The FDA issued an alert about the potential failure of EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors and authorized generics.
Pfizer, the manufacturer of the EpiPen, and Mylan said the devices may activate prematurely if their blue safety release is removed using a sideways force. A limited number of devices may have a blue safety release that is slightly raised and this also could cause the device to activate prematurely.
Additionally, some of the 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 companies said.
The FDA urged patients and caregivers to inspect the devices to ensure the blue safety release is not raised and that the device can be easily removed from the carrier tube.