on March 31, 2017, 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. Both reports are related to the single lot that was previously recalled by Meridian. 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 by Meridian to include additional lots as a precautionary measure out of an abundance of caution.
The recall impacts certain lots of 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.
The recalled product was manufactured and distributed by Meridian between December 2015 and July 2016. The expanded voluntary recall is being initiated in the U.S. The recall also will extend to additional markets in Europe, Asia, North and South America.
Epinephrine is the first-line treatment for a life-threatening allergic reaction (anaphylaxis) and access to this product is critical in the event of an emergency. Delays in epinephrine administration have been associated with negative health consequences.
More information about the risks and benefits of EpiPen®
Auto-Injector can be found at EpiPen.com