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.

Product name/Active Pharmaceutical Ingredient DIN Strength Lot # TEVA-VALSARTAN/HCTZ TABLETS PP 30s 02357046 320/25 mg 35212731R ACT-VALSARTAN 40MG FC TABLETS 100 02337487 40 mg K47338 ACT-VALSARTAN 80MG FC TABLETS 100 02337495 80 mg K45370 ACT-VALSARTAN 80MG FC TABLETS 100 02337495 80 mg K47652 ACT-VALSARTAN 80MG FC TABLETS 100 02337495 80 mg K47653 ACT-VALSARTAN 80MG FC TABLETS 100 02337495 80mg K47654 ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K39691 ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K44167 ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K47657 ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K47658 ACT-VALSARTAN 320MG FC TABLETS 100 02337517 320 mg K44166 ACT-VALSARTAN 320MG FC TABLETS 100 02337517 320 mg K45371 SANDOZ VALSARTAN 40 MG 02356740 40 mg All lots SANDOZ VALSARTAN 80 MG 02356759 80 mg All lots SANDOZ VALSARTAN 160 MG 02356767 160 mg All lots SANDOZ VALSARTAN 320 MG 02356775 320 mg All lots SANIS VALSARTAN 40 MG 02366940 40 mg All lots SANIS VALSARTAN 80 MG 02366959 80 mg All lots SANIS VALSARTAN 160 MG 02366967 160 mg All lots SANIS VALSARTAN 320 MG 02366975 320 mg All lots PRO DOC LIMITEE VALSARTAN 40 MG 02367726 40 mg All lots PRO DOC LIMITEE VALSARTAN 80 MG 02367734 80 mg All lots PRO DOC LIMITEE VALSARTAN 160 MG 02367742 160 mg All lots PRO DOC LIMITEE VALSARTAN 320 MG 02367750 320 mg All lots SIVEM PHARMACEUTICAL ULC VALSARTAN 40 MG 02384523 40 mg All lots SIVEM PHARMACEUTICAL ULC VALSARTAN 80 MG 02384531 80 mg All lots SIVEM PHARMACEUTICAL ULC VALSARTAN 160 MG 02384558 160 mg All lots SIVEM PHARMACEUTICAL ULC VALSARTAN 320 MG 02384566 320 mg All lots

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866-225-0709

What Health Canada is doing

Health Canada is monitoring the companies’ recalls. Should additional safety information be identified, Health Canada will take appropriate action and inform Canadians.