Mylan Voluntarily Recalls 80,000 EpiPens Worldwide
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 include additional lots distributed in the US and other markets in consultation with the US Food and Drug Administration (FDA), following an earlier EpiPen recall by Mylan in Australia.
The recall was initiated based on two global reports confirming that the device failed to activate due to a potential defect in a supplier component in a batch of about 80,000 devices. 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).
The recall applies to product manufactured by Meridian Medical Technologies at its facility in St. Louis, Missouri and distributed by Mylan Specialty between December 2015 and July 2016.
In Australia, the recall was issued by Alphapharm Pty Ltd, a Mylan company, for batches of EpiPen 300 microgram Adrenaline Injection Syringe Auto-Injectors. In the US, the recall impacts the 0.3-mg and 0.15-mg strengths of EpiPen Auto-Injector. In addition to Australia and the US, the recall will also extend to additional markets in Europe, Asia, and North and South America. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies.
