FDA Announces Voluntary Recall of EpiPen and EpiPen Jr
13 lots of Mylan products are being voluntarily recalled.
The Food and Drug Administration is alerting consumers to Meridian Medical Technologies' voluntary recall of 13 lots of Mylan's EpiPen and EpiPen Jr. Auto-Injector products. The products may contain a defective part that could result in a failure to activate.
The 13 identified lots were distributed between Dec. 17, 2015, and July 1, 2016, and they are the only lots affected by the U.S. recall. "Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date," according to the agency's notice.
It said that, "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. Consumers should keep and use their current EpiPens if needed until they get a replacement. Consumers should contact Mylan at 800-796-9526 or [email protected] with any questions."