The FDA's Sept. 5 warning letter to Pfizer's Meridian Medical Technologies unit includes new details surrounding a global recall of EpiPen and EpiPen Jr. in March. The FDA letter says the company failed to investigate problems with the devices, recall batches and act on problems, including expanding its internal investigation after two customer complaints of EpiPen failures were traced to a deformed component. It's not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals," Pfizer said in an emailed statement. "We currently have no information to indicate that there was any causal connection between these product complaints and any patient deaths." Both Mylan and Pfizer said they are confident in the safety and efficacy of EpiPen products being produced at the site.

Source: CBC News September 08, 2017 12:45 UTC