Meridian Medical Technologies last week announced that it was expanding a voluntary recall of its EpiPen and EpiPen Jr. epinephrine auto-injector products to include 13 U.S. lots distributed between December 2015 and July 2016. At issue is a possible defect in the devices that could result in their failing to activate in a life-threatening situation.
Pfizer subsidiary Meridian manufactures the auto-injectors, which are distributed in the United States by Mylan Specialty.
"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 said in a news release(newsroom.mylan.com). "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."
The March 31 recall comes on the heels of a previous recall announcement that followed two reports from outside the United States of the device failing to activate; both patients were successfully treated with backup devices. The initial recall involved a single lot of overseas product -- about 81,000 devices.
The expanded recall involves product in Europe, Asia, and North and South America.
The recall involves the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. None of the recalled lots includes the generic version of the EpiPen Auto-Injector, which Mylan also manufactures.
Further information about the recalled lots, including specific lot numbers, is available on Mylan's website(www.mylan.com). Instructions on how to obtain a voucher code for a free replacement, as well as how to return affected product, may also be obtained by calling product recall specialist Stericycle at 877-650-3494, Monday through Friday from 8 a.m.-10 p.m. ET, and Saturday and Sunday from 8 a.m.-5 p.m. ET.
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