Incorrect Dosages Prompt Recall of Dobutamine Hydrochloride Injection

Incorrect Labeling States Dosage at 1000 times above Indicated

Certain lots of Dobutamine Hydrochloride Injection 250 mg/20 ml are being recalled due to a labeling error which indicates units of measure for dosing 1000 times higher than recommended.

The recall has been issued by Novopharm Ltd., in consultation with Health Canada. So far, 3 lots of this product are being recalled. They are: Lot 957734 (expiry date: June 30, 2009), Lot 957735 (expiry date: September 30, 2009) and Lot 1156284 (expiry date: April 30, 2010).

Dobutamine hydrochloride is indicated in the treatment of adults with cardiac decompensation due to depressed contractility resulting from organic heart disease or following cardiac surgical procedures in which parenteral therapy is necessary for inotropic support.

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Published on Jan-12-09