Risk of EpiPen Auto-Injectors Failing to Activate Prompts Mylan to Expand Worldwide Recall

The potential defect could have significant health consequences for a patient experiencing a life-threatening allergic reaction

EpiPen 2-Pak Auto-Injector recall
Image: NCCC
April 04, 2017

Mylan has announced that Meridian Medical Technologies, Mylan's manufacturing partner for the EpiPen Auto-Injector, has expanded a recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr (epinephrine injection, USP) Auto-Injectors. Now, additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA) are also being included in the recall.

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 recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North America, 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. 

To view a full list of the impacted EpiPen lots in the U.S., click here.

Mylan says that it is committed to replacing recalled devices at no cost to consumers and 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's website for updates on product return and replacement instructions. Mylan is asking patients to keep their existing product until their replacement product can be secured.

Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability. The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector.

It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device. 

To return your product please contact Stericycle at (877) 650-3494. Consumers with any additional questions or concerns about this recall can contact Mylan Customer Relations at (800) 796-9526.