Mylan announces expanded recall of EpiPen, EpiPen Jr

Recall of additional lots is a ‘precautionary measure’ after two reports of activation failure

Meridian Medical Technologies, Mylan’s manufacturing partner for EpiPen auto-injector, has expanded a voluntary recall of EpiPen and EpiPen Jr auto-injectors (epinephrine injection) to include additional lots distributed in the United States as well as in Europe, Asia, North America, and South America. The recall is being expanded because the device—which failed to activate in two previously disclosed incidents outside of the United States—may have a defect in a supplier component, Mylan said in a news release.

The potential defect could make the device difficult to activate in an emergency and have significant health consequences for a patient experiencing a life-threatening allergic reaction. Both reports are related to the single lot that was previously recalled.

Mylan noted that the incidence of the defect is extremely rare, and testing and analysis across the potentially affected lots has not identified any units with a defect.

The recall affects the 0.3-mg and 0.15-mg strengths of EpiPen auto-injectors distributed between December 2015 and July 2016. None of the recalled lots include the authorized generic for EpiPen auto-injector, which is also manufactured by Meridian Medical Technologies, Mylan noted. Patients may receive either EpiPen auto-injector or the authorized generic at the pharmacy as a replacement based on availability. The authorized generic has the same drug formulation and operating instructions, is therapeutically equivalent to EpiPen auto-injector, and may be substituted for EpiPen auto-injector.

Patients, customers, and distributors are being notified of the recall and can visit Mylan.com/EpiPenRecall for updates on product return and replacement instructions. The company will replace recalled devices at no additional cost.

Patients should continue to carry their current EpiPen auto-injector until they receive a replacement device, according to Mylan.