Update on Meridian’s Voluntary Worldwide Recall of EpiPen®Auto-Injector
Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen® (epinephrine injection, USP) Auto-Injector, has expanded a voluntary recall of select lots of EpiPen and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA).
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. Both reports are related to the single lot that was previously recalled by Meridian. 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 by Meridian to include additional lots as a precautionary measure out of an abundance of caution.