FOOD AND DRUG
ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
April 15, 1998PRODUCT
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. |
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