Several drugs containing valsartan being recalled due to contamination with a potential carcinogen
- Starting date:
- July 9, 2018
- Type of communication:
- Source of recall:
- Health Canada
- New safety information
- General Public
- Identification number:
- What you should do
- Who is affected
- Media enquiries
- Public enquiries
- What Health Canada is doing
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|
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.