The U.S. recall applies to 13 lots distributed between December 2015 and July 2016, which Raffat estimated at about 260,000 devices. It's believed that this defect will make it hard to operate the device in case of emergency situations and can be life-threatening for anaphylaxis patients.
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Mylan's EpiPen manufacturing partner, Pfizer subsidiary Meridian Medical Technologies, has expanded its voluntary recall of the epinephrine autoinjector to include products distributed in the US and other markets after discussions with the Food and Drug Administration.
Mylan investors had all reasons for concern when the company announced the recall of its EpiPens post market hours on Friday.
The recall was initiated after there were two complaints - both outside of the United States - about the device not getting activated probably due to a defect in a supplier component. The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. None of the recalled lots includes the authorized generic for the EpiPen, which is also manufactured by Meridian. Auto-Injector and EpiPens voluntarily recalled certain models after the reports came in that there was failure to activate the device properly and thus the medication was not deployed effectively.
Even if an EpiPen is included in the recall, the FDA is instructing consumers to keep and use the recalled auto-injectors until their replacements arrive, adding that "consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate". Mylan did not immediately respond to a request for information about how many EpiPens are affected by the latest recall.
This isn't the first time an epinephrine auto-injector has been pulled from the shelves.