The voluntary move is an expansion of an earlier recall triggered by reports the device had failed to activate. The recall is now global, including EpiPen batches in Asia, Europe, and the Americas.
“The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis),” Mylan, the maker of the product, said in a press release.
According to Mylan, the defect is “extremely rare," but the recall is nonetheless being expanded “as a precautionary measure out of an abundance of caution.”
EpiPen has been under fire since a massive price hike last year left many allergy suffers unable to afford it. The public outcry resulted in a congressional hearing and a serious fall in Mylan’s stock value.
Now, many who previously relied on EpiPen have switched to Adrenaclick, a generic version of the drug manufactured by Impax Laboratories. This product has not been recalled.