FDA Medical Bulletin * June 1996 * Volume 26 Number 2
Fatalities have been reported from inadvertent administration of excessive doses of concentrated Epinephrine Injection (1 mg/mL) from 30-mL (total drug content, 30 mg) multiple-dose vials. Because of the wide range of epinephrine-containing injectable products on the market, confusion is possible, especially in an emergency. Therefore, the labeling of these concentrated 30-mL vials is being improved so that the strength and total contents of the vial are more distinguishable. However, as an additional safeguard, the storage of these vials on emergency carts and as floor stock should be restricted.
REPORT SERIOUS ADVERSE EVENTS AND PRODUCT PROBLEMS TO MEDWATCH
1-800-FDA-1088