Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences

spacer.gif (43 bytes)

FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
April 15, 1998

PRODUCT
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.
NDC #0074-2347-32.

Recall #D-113-8.

CODE

28-488-DR, 28-490-DR, 28-491-DR, 29-497-DR.

MANUFACTURER

Abbott Laboratories, North Chicago, Illinois.

RECALLED BY
Manufacturer, by letter dated March 20, 1998.
Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide and The Netherlands.

QUANTITY

29,952 units were distributed; firm estimated that
3,000 units remained on market at time of recall
initiation.

REASON

Mislabeling -- Some correctly labeled 500 mg units
are over wrapped with an incorrect 250 mg foil
labeled pouch.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.