Health Canada announced late Friday evening that Auro Pharma was recalling certain lots of losartan tablets due to the presence of an azide impurity.
This medication is used in particular in the treatment of chronic heart failure, kidney damage in people with diabetes, high blood pressure and to prevent stroke.
The company is recalling seven lots of 25 mg, 50 mg and 100 mg losartan tablets after testing above the acceptable level of an azide impurity.
Long-term exposure to concentrations of this impurity above the threshold considered safe could increase the risk of cancer, said Health Canada in its press release.
This recall is added to a long list affecting several pharmaceutical companies since May 30, always for the same reasons: the presence of an azic impurity in losartan, irbesartan, or valsartan tablets.
In particular, Health Canada announced on September 16 that Sandoz Canada inc. and Sanis Health inc. were recalling Teva-Losartan and Sivem-Losartan.
Other pharmaceutical companies affected by this round of recalls are Teva Canada, Sun Pharma Canada, Pro Doc, Sivem Pharmaceuticals ULC, Pharmascience and Mint Pharmaceuticals.
The expiration date of some of these products can go up to December 2023.
The ministry expects manufacturers to take whatever steps are necessary to reduce or eliminate the azide impurity, Health Canada said. Affected companies have been ordered to implement control measures to ensure that the level of impurity in their products is at or below the acceptable level.
In the meantime, Health Canada recommends that users continue to take your medicine, unless the healthcare provider has advised them to stop.
There is no immediate risk to patients taking these drugs, since the increased risk of cancer is linked to long-term exposure to the impurity. It may be riskier for your health not to treat your condition., assures the agency.
She also asks users to report any side effects to her. She also recalls that pharmacists may be able to provide a product not affected by the recall, or that a doctor may prescribe another medication.