Thirteen lots of EpiPen and EpiPen Jr products in the U.S. are being recalled because of a potential defect that could prevent the epinephrine injector devices from activating.
The recall is an expansion of a recent recall that followed two reports of the product failing to deliver its dose due to a defective part. That recall involved about 80,000 EpiPens in Australia, Europe, Japan and New Zealand.
Distributed between Dec. 17, 2015, and July 1, 2016, the EpiPen 2-Pak and EpiPen Jr 2-Pak products contain 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector used for emergency treatment of severe allergic reactions. The devices were manufactured by Meridian Medical Technologies and distributed by Mylan Specialty. The generic EpiPen Auto-Injector made by Meridian is not part of the recall.
Consumers and distributors are being notified of the recall and should call 877-650-3494 or visit www.mylan.com/en/epipenrecall for instructions on return and replacement of the products. Patients are advised to carry and use their current EpiPens, if needed, until they obtain a replacement.
For a list of the recalled lots of EpiPens, go to www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm550170.htm. Read the safety alert from the Food and Drug Administration (FDA) at www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm550165.htm. For additional questions on the recall, contact Mylan at 800-796-9526.
For information on the EpiPen recall in Canada, visit www.pfizer.ca/node/7651.
The FDA is continuing to investigate the devices’ failure to activate. Health care professionals and patients are asked to report adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report or by calling 800-332-1088.