Pharmaceuticals company Mylan, which distributes the Epipen, a device for severe allergic reactions, is back in the news.
Mylan on Friday disclosed a possible defect in some of the devices, months after embroiling itself in controversy and a congressional investigation last year by dramatically raising the list price of the life-saving injector to over $600 for a pack of two.
Meridian Medical Technologies, which makes Mylan’s Epipens, issued a voluntary recall of 13 lots of injectors distributed between Dec. 17, 2015, and July 1, 2016.
Some Epipens may have a defective injector, the company said in a statement.
“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,” Mylan said.
While “the incidence of the defect is extremely rare,” the company is recalling them as a necessary precaution, given that it could be a matter of life and anaphylaxis-induced death.
Mylan will replace defective injectors at no charge.
Congress investigated Mylan last September after the Epipen price increased by more than 500 percent in recent years. The investigation probed how much taxes Mylan pays on the devices and how much it profits from sales.
CEO Heather Bresch at the time pushed back on the allegations of overpricing.
