The U.S. Food and Drug Administration (FDA), is alerting consumers that Meridian Medical Technology is voluntarily recalling 13 lots of Mylan’s EpiPen and EpiPen Jr. Auto-Injector products due to a defect that may cause the devices to fail to activate. Although the number of reported failures is relatively small, EpiPen products containing a defective part that causes the device to fail creates the potential for life-threatening risk when a severe allergic reaction goes untreated.
The recalled lots identified by the FDA are the 0.3 mg and 0.15 mg strengths that were distributed between December 17, 2015 and July 1, 2016, not including the authorized generic version. Patients can receive another EpiPen or a generic version at their pharmacy and in the meantime, Mylan is advising them to continue to carry and use their current EpiPen until they obtain a replace
What are EpiPens?
EpiPens are spring-loaded syringes filled with epinephrine, a potentially life-saving medication used when someone shows signs of a life-threatening allergic reaction to insect bites, foods, drugs, or other substances. Epinephrine acts quickly to improve breathing, stimulate the heart, raise blood pressure, reverse hives, and reduce swelling of the face, lips, and throat.
Pressing the EpiPen into a person’s thigh, which is the prescribed area for administration, causes a needle to penetrate skin and inject epinephrine into muscle. The defective part may require a person to use increased force to activate the needle, or it may prevent the EpiPen from working at all, according to Mylan.
Other Headaches for Mylan Over EpiPen
On April 3, a class-action racketeering lawsuit was filed against Mylan. The lawsuit alleges that the company engaged in an illegal scheme when it dramatically raised the price of the EpiPen over the past decade from $90 to more than $600 for a two pack of the devices. People who either have limited insurance coverage or no insurance at all must pay the list price for the device.