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FDA Recalls Mylan EpiPen and EpiPen Jr.


— April 7, 2017

Mylan isn’t doing so well lately. Not only is it currently grappling with numerous lawsuits over their suspicious EpiPen pricing, but now the U.S. Food and Drug Administration has issued a huge recall of the company’s EpiPen and EpiPen Jr. over concerns that the emergency injectors could fail to activate because of a defective part.


Mylan isn’t doing so well lately. Not only is it currently grappling with numerous lawsuits over their suspicious EpiPen pricing, but now the U.S. Food and Drug Administration has issued a huge recall of the company’s EpiPen and EpiPen Jr. due concerns that the emergency injectors could fail to activate because of a defective part.

At the moment, there are 13 affected lots that were distributed between December 2015 and July 2016, and while the recall includes “both the 0.3 and 0.15 mg strengths of EpiPen,” it does not include the generic version. They were manufactured “by Meridian Medical Technologies,” and are used by families and individuals across the world to “treat severe allergic reactions with a dose of epinephrine.”

Image of the outside of Mylan Laboratories Inc.
Mylan Laboratories Inc.; Image Courtesy of the Pittsburg Post-Gazette, http://www.post-gazette.com/

So far there have been very few “reports of failure,” but even a few are too many when you consider the fact that “an untreated reaction can be life-threatening.” Two of the reports that have been submitted so far occurred outside the U.S. when the device failed to activate. Additionally, the defect “could cause the life-saving device to require increased force in order to activate, or to fail altogether — resulting in significant danger for a patient having an allergic reaction.” That’s why both the FDA and Mylan are encouraging people to “keep and use their current EpiPens until they receive a replacement,” because in this case, even a faulty EpiPen is better than no EpiPen.

Consumers who don’t know if they have a faulty device can “check their EpiPens against Mylan’s list of affected lot numbers and return any recalled products by calling Stericycle at 877-650-3494.” According to an article in Good Housekeeping, people can receive a voucher to receive a new injector at their pharmacy, and if anyone has questions about the recall, they can contact Mylan at 800-796-9526 or customer.service@mylan.com.

Sources:

Mylan recalls EpiPen auto-injectors due to failure to activate

FDA Announces Nationwide EpiPen Recall

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