Letter cites complaints that device doesn’t work in emergencies
by MedPage Today Staff September 08, 2017
The FDA sent a warning letter to a Pfizer manufacturing unit that makes EpiPens for Mylan, saying the company failed to properly investigate “serious product failures,” MarketWatch reports.
The agency said Meridian Medical Technologies continued to make a potentially defective product while hundreds of complaints poured in about EpiPens failing to work in emergencies — “including some situations in which patients subsequently died,” the FDA letter stated.
Meridian originally discovered the issue in February 2016; only a single recall was initiated last March.