Voluntary Drug Recall by Pro Doc Limitée of Irbesartan

Two lots of irbesartan drugs distributed in Quebec are voluntarily recalled

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.

Irbesartan is part of 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.

 The recalled lots are:

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

NDEA is classified as a probable human carcinogen. 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.

To know what you should do, or for more information, please consult Health Canada’s Information Update : Pro Doc Limitée voluntarily recalls two lots of irbesartan drugs because of nitrosamine impurity.