A company beneath the umbrella of pharmaceutical giant Pfizer has initiated a clawback of its recalled EpiPen Auto-Injector and EpiPen Jr Auto-Injector for failing to activate in time of need.
The U.S. Food and Drug Administration notified the public March 31, 2017 about the recall by Meridian Medical Technologies / Mylan N.V. The agency stated in a news release that 13 lots of the epinephrine-injection products might have a defective part.
“While the number of reported failures is small, 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,” according to the release.
There have been two instances of the device failing outside the United States that have put users at risk of anaphylaxis – an allergic reaction so severe that it is life-threatening. The recall was initiated domestically and will be implemented in markets in Asia, Europe and South America. Still, the FDA asks consumers who require the devices to keep them until a replacement is obtained. None of the 13 lots in question affects the generic EpiPen Auto-Injector, also manufactured by Meridian Medical Technologies.
“The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector,” Mylan N.V. states on its Web site.
Recommendations in the wake of the recall are for consumers to visit mylan.com/epipenrecall for information and updates and to learn how and where to return their device once a replacement is obtained. Healthcare practitioners are asked to report any adverse events involving the EpiPen Auto-Injector or EpiPen Jr Auto-Injector by downloading an FDA form. They also can call 800-332-1088.