Two device failures lead Mylan to recall more than 80,000 EpiPens overseas.
Two EpiPens failed to work correctly in emergency situations overseas, which resulted in Mylan NV recalling around 81,000 of the devices in Europe, Australia, New Zealand, and Japan, according to Stat and Reuters. In both cases, the people using the devices were treated for allergic reactions with a second available EpiPen.
The recall is in effect only outside the United States. The company says that it is working with authorities in the countries affected by the recall.
The devices being recalled are in four batches that contain 300 mcg of epinephrine-Batches 5FA665, 5FA6651, 5FA6652, and 5FA6653-according to a statement from Mylan in Australia. They may contain a defective part that that could cause them to fail to activate or which require added force to activate. This failure could result in the patient not receiving enough epinephrine during an anaphylactic reaction, which can be life-threatening. All the devices in these batches have April 2017 expiration dates.
People who have EpiPens from those batches are being instructed to return them to a pharmacist who will replace them with devices from another batch free of charge, according to the statement. They are also being instructed to keep their current EpiPen until they get a replacement, and to use it if it is needed.
In Europe, the recall is being conducted in Ireland, Finland, Denmark, Norway, and some other countries. EpiPens are manufactured for Mylan by Meridian Medical Technologies, a U.S. subsidiary of Pfizer.
Mylan has been the subject of several federal investigations in the United Sates because of extreme price increases for EpiPen. It has also received criticism for classifying EpiPen as a generic instead of a branded product, which means that it is subject to much smaller rebates from the company to state Medicaid programs.