In Dangerous Drugs Blog

EpiPen RecallOn March 31, 2017, pharmaceutical giant Mylan N.V. announced an expansion of its voluntary recall of select lots of EpiPen and EpiPen Jr. Auto-Injectors, manufactured by its partner, Pfizer’s Meridian Medical Technologies, for their “failure to activate.” This expanded EpiPen recall was announced just days before Mylan was hit with a class-action racketeering lawsuit for an alleged scheme to raise the price of EpiPens.

The EpiPen Auto-Injector is a medical device used to inject measured doses of epinephrine (adrenaline) in order to combat anaphylactic shock, a severe allergic reaction. The recall of the EpiPen lots was initiated following two reports of the device’s failure to activate because of a potential defect that could make the EpiPen difficult to use during an emergency. The failure to activate could have significant, potentially fatal health consequences for a patient suffering a serious allergic reaction. While the initial recall was limited to only one lot, it has been expanded to include others as a “precautionary measure out of an abundance of caution.”

The recall impacts 0.15 mg and 0.3 mg EpiPen and EpiPen Jr. Auto-Injectors that were distributed between December 2015 and July 2016. Authorized generic EpiPens are not included. The recall is being conducted with the knowledge of the Food and Drug Administration (FDA).

Class-Action Lawsuit

In an additional setback for the Pennsylvania-based company, a class-action lawsuit for racketeering was filed against Mylan on April 3. The suit alleges that Mylan illegally increased EpiPen prices over the past decade as a result of rebate payments to pharmacy benefits managers. By doing so, the lawsuit argues, Mylan may have violated consumer protection laws.

Mylan stated that it would replace all impacted EpiPen and EpiPen Jr. Auto-Injectors at no cost. To return the products, consumers may contact Stericycle at (877) 650-3494. If they have any additional questions, they may also contact Mylan Customer Relations at (800) 796-9526. Customers are urged to continue carrying their EpiPens with them until replacements arrive.