Information Update - Pro Doc Limitée voluntarily recalls two lots of irbesartan drugs because of nitrosamine impurity

OTTAWA, March 13, 2019 /CNW/ - Health Canada is advising Canadians that Pro Doc Limitée is voluntarily recalling two lots of irbesartan tablets because of a nitrosamine impurity, N-nitrosodiethylamine (NDEA). The lots were distributed in Quebec only.

NDEA is classified as a probable human carcinogen, which means that long-term exposure could increase the potential risk of cancer. Pro Doc Limitée is conducting the recall after 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.

The irbesartan active pharmaceutical ingredient (API) in the recalled lots is manufactured by Teva API India Ltd. An API is the active ingredient in a drug that produces an effect on the body. APIs are used in the manufacturing of finished dosage form drugs (such as pills, capsules or tablets). 

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 that exceed safe levels. Patients should not stop taking their medication unless advised to do so by their health care 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
The following Pro Doc Limitée irbesartan products are being recalled 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
IRBESARTAN (PRO DOC LIMITEE)	02365200	150 mg	604292	10/2019
IRBESARTAN (PRO DOC LIMITEE)	02365219	300 mg	601795	08/2019

What you should do

• Continue taking your irbesartan 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 Pro Doc Limitée by calling toll-free at 1-800-361-8559 (select "Option 1"), 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 (2019-03-11): 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

For further information: Media Enquiries: Health Canada, [phone]; Public Enquiries: [phone], 1-866 225-0709