|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
April 15, 1998
Dobutamine in 5% Dextrose Injection, 500 mg (2000
mcg/mL), in 250 mL flexible containers with foil
overwrap, Rx intravenous solution for inotropic
support in the short-term treatment of adults with
cardiac decompensation due to depressed
contractility resulting either from organic heart
disease or from cardiac surgical procedures.
28-488-DR, 28-490-DR, 28-491-DR, 29-497-DR.
Abbott Laboratories, North Chicago, Illinois.
Manufacturer, by letter dated March 20, 1998.
Firm-initiated recall ongoing.
Nationwide and The Netherlands.
29,952 units were distributed; firm estimated that
3,000 units remained on market at time of recall
Mislabeling -- Some correctly labeled 500 mg units
are over wrapped with an incorrect 250 mg foil