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The FDA has announced Mylan’s expanded recall of select lots of its EpiPen Auto-Injector and EpiPen Jr. Auto-Injector. This follows the original recall that the company announced in March 2017. Initially, they recalled units sold only in Australia, due to a potentially defective part that could result in the device failing to activate as expected.

The new recall expands the original to include additional lots sold in the U.S. and concerns the same problem. It affects 13 lots of the injectors distributed between December 17, 2015, and July 1, 2016. The FDA has assured customers that they do not need to replace injectors from lots outside the recall prior to their expiration dates.

Mylan Recalls EpiPen Auto-Injector for Potential Defective Component

Mylan’s subsidiary Alphapharm voluntarily implemented the recall after receiving two reports of the auto-injectors failing to activate due to a potential defect in one supplier component. The defect could make the device difficult to activate in an emergency, which could in turn lead to serious health risks for those who rely on the devices during emergency allergy attacks.

Both of the reports were related to the lot that was originally recalled in Australia (New Zealand, Europe, and Japan were also affected). So far, the incidence of the defect seems to be rare. The recall affects the 0.3 mg and 0.15 mg strengths of these injectors and doesn’t affect any of the authorized generic versions of the EpiPen. For a list of the recalled lots impacting U.S. users, please see the FDA’s recall announcement.

Mylan assures customers that it will replace recalled devices at no cost, and has provided the Mylan recall website for information on how to receive a replacement.

What is the EpiPen Auto-Injector?

The EpiPen Auto-Injector provides emergency epinephrine to allergy patients experiencing “anaphylaxis,” a life-threatening allergy attack. Symptoms usually include difficulty breathing, wheezing, hives, low blood pressure and severe skin itching. The injector delivers a dose of injection of epinephrine which helps relax the lungs and improve breathing, while also increasing blood pressure and reducing hives and swelling.

Epinephrine (also known as adrenaline) is the only first-line recommended treatment for anaphylaxis. Because it is usually the only option to subdue a frightening allergy attack, it can be especially dangerous if the EpiPen doesn’t work as described.

EpiPen Class Action Lawsuit

The recall comes on the heels of a new EpiPen class action lawsuit, which was filed in the U.S. District Court for the Western District of Washington in early April 2017. The plaintiffs claim that the drug maker took advantage of consumers by increasing the list prices of the life-saving devices seventeen times since receiving approval to market the drug in 2007.

The price started out at $90.28 and was most recently $608.62, an increase of 574 percent.

Plaintiffs assert that Mylan participated in and benefitted from the high list price scheme, and from paying high rebates or kickbacks to pharmacy benefit managers, or intermediaries, to ensure that EpiPen remained the dominate epinephrine emergency treatment.

The plaintiffs bring counts of violation of the Racketeer Influenced and Corrupt Organizations Act (“RICO”), along with various state-based deceptive trade practices acts, for a total of 55 counts altogether. They seek $5 million in damages.

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