Mar 21, 2012 / 8:30 pm
Health Canada is warning Canadian hospitals and health-care providers to immediately stop using and quarantine a Sandoz Canada drug product after a box of injectable morphine was found to contain another powerful drug that had been mislabelled.
Sandoz informed Health Canada on Wednesday that a hospital had reported that one package of 2 mg/ml morphine sulfate injection had been found to contain ampules labelled as 0.2 mg/ml isoproterenol hydrochloride injection in addition to ampules labelled as containing morphine.
Inadvertent use of injectable isoproterenol hydrochloride instead of injectable morphine sulfate can result in serious health effects, Health Canada said in a release.
Not only would patients not receive their intended morphine therapy, but isoproterenol hydrochloride is a powerful agent associated with a risk of abnormal heart rhythms, which may be life-threatening. Other side-effects may include headache, tremor and sweating.
Sandoz has told Health Canada that it cannot confirm whether there are other similar packages with mislabelled drug contents.
Health Canada is working with the drug company to determine the scope of the problem and to ensure that other incorrectly packaged products do not make their way into the drug-supply system. The federal agency has also informed the provinces and territories.
Sandoz Canada, which supplies the majority of injectable medications used in Canada, among them painkillers, anti-nausea medications and antibiotics, is at the centre of a national drug shortage caused by quality-control problems at its Boucherville, Que., plant.
The affected products are:
-Morphine sulfate injection USP, 2mg/ml (1ml), DIN 2242484, UPC 057513056420, Lot CC2824 exp. 2014-12
-Isoproterenol hydrochloride injection USP, 0.2 mg/ml (1ml), DIN 897639, UPC 057513046001, Lot CB8787, exp. 2012-11
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