A voluntary recall of select lots of EpiPen and EpiPen Jr® Auto-Injectors was announced March 31, 2017 by Mylan N.V. for Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner.
This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. 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). Both reports are related to the single lot that was previously recalled. The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.
Click here to read the Mylan news release.
Click here to read the FDA news release.