Mylan NV's manufacturing partner for EpiPen, Meridian Medical Technologies, expanded the voluntary recall of EpiPen devices to include additional lots distributed in the U.S. and other markets.
The company's unit Alphapharm Pty Ltd. previously recalled several batches of EpiPen devices in several countries outside the U.S. over two global reports of device failure.
Mylan said the incidence of the defect is "extremely rare," and analysis across the potentially impacted lots has not identified any units with a defect. It added that the recall is being expanded to include additional lots as a precautionary measure "out of an abundance of caution."
The company is recalling 13 batches of EpiPen and EpiPen Jr. products and will replace any of the affected devices free of charge. Recalled devices were distributed by Mylan's unit Mylan Specialty LP between December 2015 and July 2016.
The expanded voluntary recall is in consultation with the U.S. FDA and impacts the 0.3 mg and 0.15 mg strengths of the device. It is being initiated in the U.S. and will extend to additional markets in Europe, Asia, North and South America.
Meridian Medical Technologies is a unit of Pfizer Inc.