UPDATE (October 26, 2021): Mint Pharmaceuticals Inc. recalls all lots of losartan Mint Pharmaceuticals Inc. is recalling all lots of its prescription losartan tablets, in 50 mg and 100 mg strengths, after tests found an azido impurity (5-(4'-((5-(azidomethyl)-2-butyl-4-chloro-1H imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-1H tetrazole)above the acceptable limit. Long-term exposure to the impurity at levels above what is considered safe could potentially increase the risk of cancer. Refer to the Affected Products table below for information on the recalled lots, and to the section below on what you should do. Should additional recalls be necessary, the Department will update the list of affected products and inform Canadians. UPDATE (October 15, 2021): Auro Pharma Inc., Pharmascience Inc. and Sivem Pharmaceuticals ULC recall multiple lots of losartan Auro Pharma Inc., Pharmascience Inc. and Sivem Pharmaceuticals ULC are recalling multiple lots of prescription losartan tablets, in 25 mg, 50 mg and 100 mg strengths, after tests found an azido impurity (5-(4'-((5-(azidomethyl)-2-butyl-4-chloro-1H imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-1H tetrazole) above the acceptable limit. Long-term exposure to the impurity at levels above what is considered safe could potentially increase the risk of cancer. Refer to the Affected Products table below for information on the recalled lots, and to the section below on what you should do. Should additional recalls be necessary, the Department will update the list of affected products and inform Canadians. UPDATE (October 01, 2021): Auro Pharma Inc. recalls certain lots of losartan due to azido impurity Auro Pharma Inc. is recalling seven lots of prescription losartan tablets, in 25 mg, 50 mg and 100 mg strengths, after tests found an azido impurity (5-(4'-((5-(azidomethyl)-2-butyl-4-chloro-1H imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-1H tetrazole) above the acceptable limit. Long-term exposure to this impurity at levels above what is considered safe could potentially increase the risk of cancer. Refer to the Affected Products table below for information on the recalled lots, and to the section below on what you should do. Health Canada's assessment of the presence of this second azido impurity in losartan products in Canada is ongoing. Health Canada has requested that companies marketing losartan in Canada perform detailed evaluations of their manufacturing processes and controls and to conduct testing as necessary. Should additional recalls be necessary, the Department will update the list of affected products and inform Canadians. UPDATE (September 16, 2021): Sandoz Canada Inc. and Sanis Health Inc. recall multiple lots of losartan due to azido impurity Sandoz Canada Inc. and Sanis Health Inc. are recalling all lots of prescription losartan tablets, in 25mg, 50mg and 100 mg strengths, after tests found an azido impurity (5-(4'-((5-(azidomethyl)-2-butyl-4-chloro-1H imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-1H tetrazole) above the acceptable limit. Long-term exposure to this impurity at levels above what is considered safe could potentially increase the risk of cancer. Refer to the Affected Products table below for information on the recalled lots, and to the section below on what you should do. Health Canada's assessment of the issue regarding presence of this second azido impurity in losartan products in Canada is ongoing. Should additional recalls be necessary, the Department will update the list of affected products and inform Canadians. UPDATE (August 28, 2021): Certain lots of Teva-Losartan and Sivem-Losartan recalled due to azido impurity Teva Canada Ltd. and Sivem Pharmaceuticals ULC are recalling a total of seven lots of prescription losartan tablets, in 25mg, 50mg and 100 mg strengths, after tests found an azido impurity (5-(4'-((5-(azidomethyl)-2-butyl-4-chloro-1H imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-1H tetrazole) above the acceptable limit. As with the different azido impurity that Health Canada communicated about on May 30, 2021 (see below), long-term exposure to levels above what is considered safe could potentially increase the risk of cancer. Refer to the Affected Products table below for information on the recalled lots, and to the section below on what you should do. Should additional recalls be necessary, Health Canada will update the list of affected products and inform Canadians. UPDATE (June 15, 2021): sanofi-aventis Canada Inc. recalls 12 lots of irbesartan drugs due to azido impurity sanofi-aventis Canada Inc. is recalling 12 lots of prescription irbesartan tablets (brand names Avalide and Avapro, in various strengths) after tests found the azido impurity above the acceptable limit. Refer to the Affected Products table below for detailed information on the recalled lots. Should additional recalls be necessary, Health Canada will update the list of affected products and inform Canadians. Original Advisory (May 30, 2021): Multiple lots of irbesartan, losartan and valsartan drugs recalled due to azido impurity Health Canada is informing Canadians that several companies are recalling multiple lots of irbesartan, losartan and valsartan drug products after tests found an azido impurity above the acceptable limit (see list of affected products below). Irbesartan, losartan and valsartan are all prescription angiotensin receptor blocker (ARB) drugs, which are also known as "sartans." Sartans are a class of drugs used to treat patients with high blood pressure to help prevent heart attacks and stroke. They are also used in patients with heart failure or those who have had a recent heart attack. The azido impurity, 5-(4'-(azidomethyl)-[1,1'-biphenyl]-2yl)-1H-tetrazole, is considered a mutagen. A mutagen is a chemical substance that can cause a change in the DNA of a cell. These mutations may increase the risk of cancer but the specific risk for this azido impurity to cause cancer in humans is unknown. There are established international guidelines that recommend that mutagenic impurities be kept at or below a specific level because exposure to a mutagen over the long term at a level above what is considered to be safe, has the potential to increase the risk of cancer. A person taking a drug daily for 70 years that contains this azido impurity at or below the acceptable level is not expected to have an increased risk of cancer. Not all lots of irbesartan, losartan and valsartan from these companies are affected by this issue; however, it is possible that the recalls may affect the supply of some products. Patients should speak with their doctor or pharmacist to discuss alternatives should their regular prescribed drug not be available. The Department expects manufacturers to take any necessary actions to reduce or eliminate the azido impurity. Impacted companies have been directed to implement control measures to ensure that the level of the impurity in their products are at or below the acceptable level. Health Canada is monitoring the effectiveness of the recalls. Should additional recalls be deemed necessary, Health Canada will inform Canadians.
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