Mylan recalls 81,000 EpiPens after reports of failures

Generics firm Mylan has recalled about 81,000 EpiPen devices in countries outside the US, after two reports the allergy injection device failed to work in emergencies.

The company said that in both situations, patients were treated with an alternate EpiPen.

Mylan’s recall affects devices distributed in Australia, New Zealand, Europe and Japan and Mylan is working with regulators to inform them about the move.

The pens may contain a defective part, according to the company, which did not reveal whether anyone was injured as a result of the malfunctions.

The news comes at a time when Mylan is attempting to rebuild its reputation after being caught up in the drug price scandal last year.

Mylan is under investigation by federal authorities after heavy criticism for high price increases of the life-saving emergency shot.

EpiPen is Mylan’s biggest-selling product and prior to the pricing scandal generated more than a billion dollars a year for the Pittsburgh-based firm.

To counter the criticism it faced over the price of EpiPen in the US, it has produced a generic version of its own drug, at a fraction of the original price.

The company is now turning to biosimilars to boost its sales. In the US, Mylan hopes to be first to market with its near-copy of Roche’s blockbuster breast cancer drug, Herceptin (trastuzumab).

It has signed a deal with Roche allowing it to launch its Herceptin biosimilar across the world, and a US launch could come as early as September, should the FDA approve it.

Earlier this week, the FDA gave tentative approval for Mylan’s HIV combination therapy for use in developing countries as a first-line regimen for people being treated for HIV/AIDS.

The FDA gave the nod under the US President’s Emergency Plan for AIDS Relief (PEPFAR). The drugs contain a lower than standard dose of efavirenz, plus lamivudine and tenofovir disoproxil fumarate.