The FDA has blasted EpiPen manufacturers for doing nothing while users died or developed serious illnesses after using faulty products.
In a letter published this week, the agency said these deaths would have been preventable had the makers of EpiPen tested their products, or at least investigated malfunctioning reports more thoroughly.
Tens of thousands of EpiPens were recalled in March after reports from earlier this year saying the allergy-shot devices failed to work during emergencies.
It is the latest scandal for EpiPen distributor Mylan, which is known for raising the price of the life-saving devices more than 400 percent in just a few years.
Pfizer, which owns Mylan, has responded to the FDA’s accusations, saying that there is no evidence that their devices led to patient deaths.