March 24, 2020 / 5:58 PM / 11 days ago

BRIEF-FDA Posts Alerts About Epipen Auto-Injector Errors

March 24 (Reuters) - Food and Drug Administration:

* FDA - ALERTS PATIENTS AND HEALTH CARE PROFESSIONALS OF EPIPEN AUTO-INJECTOR ERRORS RELATED TO DEVICE MALFUNCTIONS AND USER ADMINISTRATION

* FDA - PFIZER AND MYLAN IN A LETTER DETAILED HOW EPIPEN DEVICES MAY ACTIVATE PREMATURELY IF BLUE SAFETY RELEASE IS REMOVED USING A SIDEWAY FORCE

* U.S FDA SAYS IT IS AWARE OF ADVERSE EVENT REPORTS ASSOCIATED WITH EPIPEN PRODUCTS

* FDA - LETTER FROM PFIZER ALSO DESCRIBES SPECIFIC EPIPEN USER ERRORS THAT CAN DELAY/PREVENT ADMINISTRATION OF INTENDED DOSE OF EPINEPHRINE Source text; (bit.ly/2wrE1wm) Further company coverage:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below