Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

Starting date:

July 9, 2018

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

New safety information

Audience:

General Public

Identification number:

RA-67202

Issue

Several drugs containing the ingredient valsartan are being recalled by their manufacturers. An impurity, N-nitrosodimethylamine (NDMA), was found in the valsartan used in these products. The valsartan was supplied by Zhejiang Huahai Pharmaceuticals. NDMA is a potential human carcinogen, which means that it could cause cancer with long-term exposure. Five companies have affected products, which are being recalled (identified in table below).

Drugs containing valsartan are used to treat patients with high blood pressure to help prevent heart attacks and stroke. These drugs are also used in patients who have had heart failure or a recent heart attack.

What you should do

• Keep taking your medicine if it contains valsartan, unless you have been told to stop by your doctor or pharmacist.

If you are taking any medication containing valsartan, speak to your pharmacist who can tell you if your medicine is being recalled.

• If you have been using an affected product, contact your health care practitioner as soon as possible to discuss your treatment options.
• If you are in a clinical trial with a product containing valsartan and have any questions, speak to the doctor treating you in the trial.
• Report side effects (adverse events) to health products to Health Canada by calling toll-free at 1-866-234-2345, or by reporting online, by mail or by fax.
• Report complaints about health products to Health Canada by calling toll-free at 1-800-267-9675, or complete an online complaint form.

Who is affected

Consumers who use any valsartan products in the table below.