Mylan has announced that Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for the EpiPen auto-injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr (epinephrine injection, USP) auto-injectors to include additional lots distributed in the United States and other markets. Meridian extended the recall after consultation with the FDA.
The announcement comes one week after Mylan said it had recalled approximately 81,000 EpiPen devices in countries outside the U.S. following two reports of failure to activate the device due to a potential defect in a supplier component. The defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and could have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis).
Both reports were 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, according to Mylan. However, the recall is being expanded to include additional lots as a precautionary measure.
The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty between December 2015 and July 2016. The expanded voluntary recall is being initiated in the U.S. and will extend to additional markets in Europe, Asia, and North and South America.
The recall affects the 0.3-mg and 0.15-mg strengths of the EpiPen auto-injector. None of the recalled lots includes the authorized generic for the EpiPen, which is also manufactured by Meridian.
Patients may receive either the EpiPen auto-injector or the authorized EpiPen generic at the pharmacy as a replacement based on availability, Mylan said. The authorized generic has the same drug formulation, has the same operating instructions, and is therapeutically equivalent to the EpiPen auto-injector, and it may be substituted for the EpiPen.
Mylan, which is the focus of several federal investigations, has come under fire in the U.S. for staggering price increases on the EpiPen device, which dispenses less a dollar’s worth of epinephrine. Mylan has also been heavily criticized for classifying EpiPen as a generic rather than a branded product, which led to much smaller rebates from the company to state Medicaid programs.