EpiPens May Malfunction, Delaying Life-Saving Med, FDA Warns!
Epinephrine auto-injectors (EpiPen 0.3 mg, EpiPen Jr 0.15 mg, and generics), used to treat severe allergic reactions, could potentially have delayed injections or fail to inject as intended as a result of device design issues or operator error, the US Food and Drug Administration (FDA) says. In an alert posted on its website, the agency says the devices could activate prematurely if "sideways force to remove the blue safety release" is applied, or if the device has a "raised blue safety release." In addition, some devices may be hard to remove from the carrier tube and user error is also a concern.
@amit-r Another problem is that some EpiPen devices may not slide out of the carrier tube easily, or at all, because of a slight deformation on the rim of the carrier tube. When this happens, the user may not be able to quickly remove the auto-injector from the carrier tube. This issue may affect any EpiPen auto-injector lot currently on the market in the US with an expiration date prior to September 2020. However, the likelihood of an auto-injector having this is "very low," the companies say. To be sure the device can be used when needed, pharmacists, patients, and caregivers should test that they can remove the device. Specifically, they should remove both carrier tubes from the S-clip, flip open the caps of the carrier tubes, and tip each carrier tube to make sure each auto-injector slides out easily.