WASHINGTON — The Food and Drug Administration warns consumers of a voluntary recall of EpiPen products, as some might contain a defective part that results in a failure to activate.
“While the number of reported failures is small,” the FDA said, “EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated.”
So far, the U.S. recall covers 13 EpiPen lots distributed from Dec. 17, 2015, to July 1, 2016. The recalled products were made by Meridian Medical Technologies and distributed by Mylan Specialty.
Mylan said in a statement that the recall will expand to Europe, Asia and North and South America.
See a complete list of lot numbers on the FDA’s page. For additional information, call Mylan at 800-796-9526 or email customer.service@mylan.com.
“There will be no additional replacement-related financial burden to [patients] as a result of this recall,” Mylan said.
The FDA advises consumers to keep their devices until they have a replacement.
It also asks both consumers and medical professionals to report any adverse reactions or device malfunctions to the FDA’s MedWatch program by submitting a report online or by downloading and completing a form, then submitting it via fax to 800-FDA-0178.
