Image courtesy of Mylan
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).
In order to initiate the recall, Mylan has instructed patients to contact Stericycle in order to receive a voucher for a replacement injector. The company's website provides the following instructions:
- Stericycle will ask you questions about your EpiPen 2-Pak® or EpiPen Jr 2-Pak® cartons to confirm if the devices come from one of the recalled lots.
- Prior to calling Stericycle, you can confirm if you are in possession of a recalled EpiPen product by checking if the lot number matches any of the lot numbers listed in the table below. If so, you need to contact Stericycle at 877-650-3494. If not, your EpiPen product is not affected by the recall and there is no further action necessary.
- If you are in possession of a recalled EpiPen product, Stericycle will initiate the process of providing a container to return the recalled medication.
- Stericycle also will collect your contact information and will begin contacting patients back on Monday, April 3, with voucher information to redeem a free replacement product.
- Patients should not return any devices affected by the recall until they have received their voucher to redeem their free replacement from their pharmacy. It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device.
To determine if your EpiPen is affected by this recall or for more information on return and replacement of a recalled EpiPen, visit Mylan's website here.