USA TODAY. There are alternative products currently available on the Canadian market. Canadians with questions about the recalls can contact: Teva Canada is voluntarily recalling two lots of combination Losartan/hydrochlorothiazide (HCTZ) tablets after testing of one lot identified levels of NMBA above what is considered reasonably safe if the drug were taken over a lifetime. - YouTube It means that the Department has identified issues with how the company is following good manufacturing processes and procedures. Canadians with questions about the recalls can contact: NMBA is potentially a human carcinogen, which means that long-term exposure could increase the potential risk of cancer. Patients with questions or concerns about any drug they are taking, including on what to do if that drug is not readily available, should speak to their healthcare professional. They are also used in patients who have had heart failure or a recent heart attack. Health Canada encourages Canadians to visit drugshortagescanada.ca for information on drug shortages and discontinuances. Health Canada encourages consumers to report any health product-related Macleods Pharmaceuticals Limited is recalling 32 lots of the popular blood pressure drug losartan after discovering trace amounts of a probable carcinogen. Health Canada also recommended that companies consider using manufacturing practices that avoid the generation and presence of all nitrosamine impurities. For questions about returning the product, contact Qualanex via email at Here are the doses, lot numbers and expiration dates of the recalled medicine:© 2020 USA TODAY, a division of Gannett Satellite Information Network, LLC. Patients should not stop taking their medication unless advised to do so by their healthcare provider. Title: Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan Author: FDA Created Date: 4/28/2019 12:28:50 PM GMPs are internationally accepted standards that help ensure that drugs are consistently manufactured, tested, stored and distributed in a way that meets Canada’s high safety and quality standards. As a precautionary measure to protect public health, the Medicines and Healthcare products Regulatory Agency (MHRA) today recalled 3 batches of Losartan tablets due to … The recalled losartan and potassium/hydrochlorothiazide combination tablets contained small amounts of N-nitrosodiethylamine, or NDEA, according to a company notice posted to "Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out," the recall notice states.The active drug ingredient was manufactured at Hetero Labs Limited in India, one of the overseas drug factories linked to Health care professionals advise patients to consult with their doctors or pharmacists before discontinuing one of the recalled blood pressure medicines or finding an alternative treatment.Discontinuing a recalled drug could cause more immediate harm than staying on the medication.Consumers with medical questions or to report an adverse event can contact Macleods at 855-926-3384 from 8 a.m. to 5 p.m. EST. Losartan is an angiotensin receptor blocker (ARB) drug, also known as a “sartan.” Sartans are a class of drugs used to treat patients with high blood pressure to help prevent heart attacks and stroke. Health Canada has tested more than 50 samples of sartan drugs and will continue to post results of any new samples it tests on its Health Canada continues to monitor the supply situation. A non-compliant rating does not necessarily indicate a product safety concern. The Losartan active pharmaceutical ingredient (API) in all of the recalled products is manufactured by Hetero Labs Ltd. Unit 1, in India. Health Canada encourages consumers to report any health product-related side effects or complaints to the Department. As with previous recalls involving nitrosamine impurities, Health Canada is advising that there is no immediate risk to patients taking these medications, since the potential risk of cancer is with long-term exposure to the impurities. APIs are used in the manufacture of finished “dosage form” drugs (such as pills, capsules or tablets).   A non-compliant rating means that Canadian companies can no longer import drugs that contain APIs from this site unless they are medically necessary.  An API is the active ingredient in a drug that produces an effect on the body. There have been multiple recalls of products containing another sartan, valsartan, in Canada and internationally since July 2018 because of nitrosamine impurities (see links below for more information). The Department will take further steps as required to confirm that appropriate and timely action is taken to protect the health and safety of Canadians. These recalls represent all lots of drugs distributed in Canada that contain Losartan API manufactured at Hetero Labs Ltd. Unit 1. OTTAWA – Health Canada is advising Canadians that multiple lots of Losartan-containing drugs are being voluntarily recalled by Teva Canada, Apotex Inc., Pharmascience Inc., and Pro Doc Limitée because of the potential for a nitrosamine impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).