FDA Warns Manufacturer for Not Addressing EpiPen Problems — Physician’s First Watch
FDA Warns Manufacturer for Not Addressing EpiPen Problems
By Kelly Young
The FDA has notified Pfizer's Meridian Medical Technologies that it has not properly investigated hundreds of reported failures of its EpiPen auto-injectors.
Some of the failures have resulted in deaths and serious illness, the agency said in a warning letter to the company.
For instance, the company found a failing unit in part of the auto-injector, causing it not to fire. While they rejected that lot, they didn't determine whether other units were similarly defective, and they continued making EpiPens with these components.
The company did not properly identify the scope and frequency of the problem, the agency said, and their response to problems was inadequate.