Mylan Provides Update on EpiPen® RecallMylan N.V. (NASDAQ, TASE: MYL) today announced that Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen® Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA).This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). Both reports are related to the single lot that was previously recalled. The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.The recalled product was manufactured by Meridian Medical Technologies, a Pfizer company, and distributed by Mylan Specialty between December 2015 and July 2016. The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America.The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies.U.S. Impacted Lots:Product/DosageNDC NumberLot NumberExpiration DateEpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg49502-501-025GN767April 2017EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg49502-501-025GN773April 2017EpiPen 2-Pak® Auto-Injectors, 0.3 mg49502-500-025GM631April 2017EpiPen 2-Pak® Auto-Injectors, 0.3 mg49502-500-025GM640May 2017EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg49502-501-026GN215September 2017EpiPen 2-Pak® Auto-Injectors, 0.3 mg49502-500-026GM082September 2017EpiPen 2-Pak® Auto-Injectors, 0.3 mg49502-500-026GM072September 2017EpiPen 2-Pak® Auto-Injectors, 0.3 mg49502-500-026GM081September 2017EpiPen 2-Pak® Auto-Injectors, 0.3 mg49502-500-026GM088October 2017EpiPen 2-Pak® Auto-Injectors, 0.3 mg49502-500-026GM199October 2017EpiPen 2-Pak® Auto-Injectors, 0.3 mg49502-500-026GM091October 2017EpiPen 2-Pak® Auto-Injectors, 0.3 mg49502-500-026GM198October 2017EpiPen 2-pak® Auto-Injectors, 0.3 mg49502-500-026GM087October 2017Mylan is committed to replacing recalled devices at no cost and Mylan would like to reassure patients that there will be no additional replacement-related financial burden to them as a result of this recall. Patients, customers and distributors are being notified and should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions. We are asking patients to keep their existing product until their replacement product can be secured.