Mylan N.V. announced that Meridian Medical Technologies has expanded a recall of certain lots of EpiPen (epinephrine injection) and EpiPen Jr (epinephrine injection) Auto-Injectors to include other lots distributed in the United States and other markets in Europe, Asia, North and South America.
The recall follows two prior reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. The defect can result in the device failing to activate or requiring increased force to activate the device in an emergency situation, which can have significant health effects for a patient experiencing anaphylaxis. The two reports are related to the one lot that was previously recalled.
The full list of recalled Lot numbers and products can be found here.
The recall affects both the EpiPen Auto-Injector 0.15mg and 0.3mg strengths. The product was distributed by Mylan Specialty between December 2015 and July 2016. The authorized generic versions of EpiPen Auto-Injector, also manufactured by Meridian Medical Technologies, are not affected by this recall.
Patients are being asked to retain their existing product until a replacement device can be secured. They may receive either an EpiPen Auto-Injector or the authorized generic version at the pharmacy based on availability.
For more information call (800) 796-9526 or visit Mylan.com.