The Mylan recall of the EpiPen has expanded to the U.S. after “extremely rare” defects were found in the allergy injectors, causing them to be ineffective for many users.
“The recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution,” Mylan, EpiPen’s manufacturer, said in a statement, according to Bloomberg.
Mylan said it’s recalling EpiPen’s from 13 lots to be exact, but people will not have to come out of their pockets to pay for the replacement pens.
“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,” according to the FDA website. “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.”
This comes a month after Mylan announced that it would be recalling about 80,000 EpiPens in Australia, Europe, Japan, and New Zealand, according to Web MD. That was after two reports surfaced that the device had failed to deliver its dose in emergency situations.
According to Mylan, the defective part of the EpiPen causes the user to have to use additional force to activate the needle, otherwise the injector might not work at all.
The recall in the U.S. will apply to EpiPen and EpiPen Jr. Injectors that were distributed between December 17, 2015, to July 1, 2016.
EpiPen users can also contact Mylan directly at 800-796-9526 or at firstname.lastname@example.org if they have any questions or concerns.
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