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HEALTH CANADA RECALLS BATCH OF OCTREOTIDE

February 6, 2006

Health Canada has issued a recall of a batch of Octreotide Acetate Omega, an injectable cancer symptom treatment that is distributed by Montreal-based Mayne Pharma Canada.

The drug, in lot number 5J970, may mistakenly contain the antipsychotic drug fluphenazine, the Canadian health agency said last week. "Accidental administration of fluphenazine can have serious health consequences including coma and death," it added.

A recall has been initiated by Omega Laboratories of Montreal. The product is distributed across Canada by Mayne Pharma Canada. Octreotide Acetate Omega is packaged in boxes of five vials. Each 2-ml glass, amber-coloured vial contains a 1-ml dose. No adverse reactions from the use of the product so far have been reported in Canada.

The drug is administered under the skin to treat severe diarrhea and other symptoms that occur with certain intestinal tumors.