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Two previous reports of device failures lead EpiPen maker to expand recall to the United States.
Meridian Medical Technologies, the manufacturing partner of Mylan, is recalling certain lots of EpiPen and EpiPen Jr. Auto-Injectors following two reports that the device failed to activate when used.
This is an expansion of a recall of EpiPens that started last week in Europe and Asia.
The device failure may be due to a defective part in the auto-injector that can cause it to fail to activate or need more force than normal to activate. Such a failure could mean that someone having a potentially life-threatening anaphylactic reaction would not receive treatment.
The recall affects 13 lots of EpiPen and EpiPen Jr. distributed in the United States between Dec. 17, 2015, and July 1, 2016, according to an FDA statement. The lots are:
Consumers who have a device from these lots are being told to keep them and use them if they are needed in an emergency until they can get a replacement. They can contact Mylan at 800-796-9526 or firstname.lastname@example.org with any questions, according to the FDA. They can also see instructions on replacing their devices at http://www.mylan.com/EpiPenRecall. Consumers who have EpiPens from lots not included in this recall do not need to replace their EpiPen if it is not expired.
Product labeling for EpiPen states that consumers should always seek emergency medical attention immediately if they use the device, whether it activates properly or not.
The FDA asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program.