The FDA issued an alert warning consumers of a nationwide voluntary recall of Mylan’s EpiPen and EpiPen JR (epinephrine injection) Auto-Injector products due to a potentially defective part that may result in device failure. The products are intended for use as an emergency treatment for severe allergic reactions.
The recall is due to 2 previously disclosed reports outside of the United States of the device’s failure to activate as a result of a possible defect in a supplier component. The defect’s incidence was limited to a single lot, but additional lots have also been recalled as a precautionary measure. The recall affects the 0.3-mg and 0.15-mg strengths, and none of the recalled lots include the authorized generic version for EpiPen Auto-Injector.
According to the FDA’s press release, Mylan intends to replace recalled devices for patients at no cost, and patients should keep their existing products until they can receive a replacement. Patients can obtain an EpiPen Auto-Injector or its authorized generic at a pharmacy as a replacement based on availability.
The recalled product was manufactured by Meridian Medical Technologies, a Pfizer company, and distributed by Mylan Specialty between December 2015 and July 2016.
Mylan Provides Update on Meridian Medical Technologies', a Pfizer Company, Expanded Voluntary Worldwide Recall of EpiPen® Auto-Injector [news release]. FDA’s website. https://www.fda.gov/Safety/Recalls/ucm550173.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
. Accessed April 3, 2017.