Recall of one lot of Dobutamine Hydrochloride Injection 250 mg /20 ml due to labelling error regarding dose - Notice to Hospitals

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Contact: Health Product and Food Branch Inspectorate (HPFBI)

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Teva Novopharm. Contact the company for a copy of any references, attachments or enclosures.

NOTICE TO HOSPITALS
Health Canada Endorsed Important Safety Information on Dobutamine Hydrochloride Injection 250 mg/20 ml

May 15, 2009

To: Hospital Chief of Medical Staff

Please distribute to relevant Departments of Pharmacy, Surgery, Emergency Medicine, Anaesthesia, Internal Medicine, Cardiology, Nursing, Intensive Care and/or other Departments who stock this product, and other involved professional staff and post this Notice in your institution.

Subject: Recall of one lot of Dobutamine Hydrochloride Injection 250 mg /20 ml due to labelling error regarding dose.

Novopharm Ltd., in consultation with Health Canada is recalling 1 lot of this product due to an error in the dosing range shown on the vial labels. The dosing instructions on these vials are labeled 2.5 to 10 mg/kg/min instead of 2.5 to 10 µg/kg/min. The printed cartons and patient information leaflets are labelled correctly. The lot being recalled is: Lot 1156283 (expiry date: March 31, 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. According to the instructions in the approved product monograph, it is to be given IV at a dilution and flow rate based on patient weight (i.e 2.5 to 10 µg/kg/minute). The labelled instructions on the vial label of the recalled product lots indicate units of measure for dosing in the mg/kg/minute range, which is 1000 times higher than normal. The correct dosing range is specified on the carton text.

Please ensure the recalled lot is immediately withdrawn from service and returned to point of sale.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any serious or unexpected adverse reactions in patients receiving Dobutamine should be reported to Teva Novopharm or Health Canada at the following addresses:

Sincerely,

original signed by

David Hatt
Manager of Compliance

David He
Pharmacovigilance and Drug Safety Officer