The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.
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 Stericycle at 877-650-3494.
As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate.
At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted 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.
The US Food and Drug Administration (FDA) has recently updated the patient instructions for epinephrine autoinjectors. The FDA recommends holding the leg firmly in place just
before and during the injection.
For EpiPen and EpiPen Jr injector, hold the pen in place for 3 seconds. Some other injectors may be held in place for up to 10 seconds. Be familiar with the manufacturer’s instructions for the type of injector you are using.
In young children, injections of epinephrine into the thigh can result in bent or embedded needles, especially if the child is moving or uncooperative during the injection. The rationale for the shortened injection duration is that it will decrease the likelihood of injury to a moving or uncooperative child.
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