Information Update - Auro Pharma Inc. voluntarily recalls one lot of Auro-Irbesartan HCT tablets because of nitrosamine impurity

OTTAWA, April 18, 2019 /CNW/ - Health Canada is advising Canadians that Auro Pharma Inc. is voluntarily recalling one lot of Auro-Irbesartan/hydrochlorothiazide (HCT) combination tablets because of a nitrosamine impurity, N-nitrosodiethylamine (NDEA). The affected lot was released in August 2018 and distributed only in Ontario and Quebec.

NDEA is classified as a probable human carcinogen, which means that long-term exposure could increase the potential risk of cancer. Auro Pharma Inc. is conducting the recall after Health Canada's testing identified levels of NDEA above what is considered reasonably safe if the drug were taken over a lifetime.

Irbesartan 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. They are also used in patients who have had heart failure or a recent heart attack.

There have been multiple recalls of products containing other sartans in Canada and internationally since July 2018 because of nitrosamine impurities (see links below for more information). Health Canada continues to work with companies and international regulatory partners, including the U.S. Food and Drug Administration and the European Medicines Agency, to assess the issue of nitrosamine impurities in certain sartan drugs, its root causes and mitigation measures.

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 impurities that exceed safe levels. Patients should not stop taking their medication unless advised to do so by their healthcare provider.

There are alternative products currently available on the Canadian market. Health Canada continues to monitor the supply situation. Health Canada encourages Canadians to visit drugshortagescanada.ca for information on drug shortages and discontinuances. 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.

Affected products
Auro Pharma Inc. is recalling the following product because of an NDEA impurity. Health Canada maintains a complete list of sartan drugs that have been recalled because of nitrosamine impurities on its website.

Product name/Active Pharmaceutical Ingredient (API)	DIN	Strength	Lot	Expiry
Auro-Irbesartan HCT	02447878	150 mg/12.5 mg	IN1518001-A	April 6, 2020

What you should do

• Continue taking your Auro-Irbesartan HCT medication unless you have been advised to stop by your health care provider.
• Contact your health care provider to discuss treatment options if you have been using an affected product.
• Ask your pharmacist if you are unsure whether you are taking a recalled product.
• Contact your health care provider if you have taken a recalled product and you have concerns about your health.
• Contact Auro Pharma Inc. by calling toll free at 1-855-568-2511, or by email at [email protected], if you have questions about the recall.
• Report any health product-related side effects or complaints to Health Canada.

Related links

• More information, including a complete list of recalled products related to this issue, and Health Canada's lab test results and test method.

Previous communications:

• Health Canada Information Update (2019-03-14): Pro Doc Limitée voluntarily recalls two lots of irbesartan drugs because of nitrosamine impurity
• Health Canada information update (2019-03-11): Multiple Losartan-containing drugs voluntarily recalled because of potential for nitrosamine impurity
• Health Canada information update (2018-12-20): Health Canada releases test results of certain sartan drugs
• Health Canada information update (2018-11-29): Mylan-Valsartan voluntarily recalled as a precaution due to an impurity
• Health Canada information update (2018-10-02): Health Canada finds Zhejiang Huahai Pharmaceuticals site non-compliant with requirements for the manufacture of drug ingredients
• Health Canada information update (2018-09-13): Health Canada advises of a second impurity linked to recalled valsartan drugs
• Health Canada information update (2018-09-10): Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA
• Health Canada information update (2018-08-18): Teva Canada expands recall of valsartan drugs to include additional lots, as a precaution
• Health Canada advisory (2018-07-09): Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

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SOURCE Health Canada

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709