Two consumer reports of a "failure to activate" in Mylan's EpiPen and EpiPen Jr. have led to a voluntary recall.
Mylan reports that after consulting with "Meridian Medical Technologies," which is its manufacturing partner and the Food and Drug Administration (FDA), the decision was made to recall certain lots of EpiPen and EpiPen Jr. The medical device is used to administer epinephrine, which is used to treat potentially fatal reactions of severe allergies, also known as anaphylactic shock.
According to a news release by Mylar, when the auto-injector fails to activate, there could be "significant health consequences for a patient experiencing a life-threatening allergic reaction." While Mylar said the incidence of this occurring is rare, the recall is being issued due to "an abundance of caution."
The reports of the defect occurred out of the U.S.; however, the company is not taking any chances. The affected lots include the .3 mg and .15 mg strengths of EpiPen Auto-Injector. Mylan noted that "none of the reported lots include the authorized generic for EpiPen auto-Injector, which is also manufactured by Meridian Medical Technologies."
More information about the recall can be found on the FDA's website, as well as at Mylan's website, mylan.com.
When a medication or medical device fails to perform as it is supposed to, there can be serious injuries or deaths. While there have only been two reports of problems with the auto-injector pen, both of them occurred outside of the U.S.
If you or a loved one have been injured because of a defect in a medical device, you do have recourse. You may choose to file a personal injury lawsuit in order to get the compensation you deserve for your injuries and damages. An attorney can provide additional information.
Source: Montana Standard, "Defect Prompts Mylan to Recall Some Epipens," April 04, 2017