activate the pen in an emergency.
There were two reports outside the U-S of pens failing to activate, and they are recalling the products out of an abundance of caution.
The maker says the issue is extremely rare, and testing has not identified any problems with any of the units in the U-S.
Details on the recall are below.
We are asking patients to keep their existing product until their replacement product can be secured.
Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability.
The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector.
Epinephrine is the first-line treatment for a life-threatening allergic reaction (anaphylaxis) and access to this product is critical in the event of an emergency. Delays in epinephrine administration have been associated with negative health consequences. More information about the risks and benefits of EpiPen® Auto-Injector can be found at EpiPen.com.