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Health Canada Widens Carvedilol Recall Over Nitrosamine Impurity

Health Canada Widens Carvedilol Recall Over Nitrosamine Impurity

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Health Canada has expanded a nationwide recall involving 25 mg carvedilol tablets, with affected products now including PMS-Carvedilol from Pharmascience as well as carvedilol distributed by Pro Doc and Sanis.

 

The recall now covers 43 lots across the three products because levels of the impurity N-nitroso-carvedilol may exceed acceptable limits. The affected medications were distributed across Canada.

 

Health Canada is stressing that patients should not stop taking carvedilol on their own because of the recall. Anyone concerned that their medication may be affected should first speak with a pharmacist or healthcare provider.

 

Patients can check the manufacturer and lot number printed on their medication package against Health Canada's recall information, or ask their pharmacist to confirm whether their supply is affected.

 

Nitrosamines can be found at low levels in some medicines, foods and drinking water, and low-level exposure is not considered an immediate health risk. However, prolonged exposure above acceptable limits may be associated with an increased risk of cancer.

 

Health Canada also warns that the risks of leaving a medical condition untreated may outweigh the potential risk from nitrosamine exposure, and patients are advised to continue their prescribed treatment until they receive professional medical guidance.