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

 Update to list of affected products

OTTAWA, July 10, 2018 /CNW/

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.

Who is affected

• Consumers who use any valsartan products in the table below.

Affected products

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 VALSARTIN 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 consumers 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.

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.

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SOURCE Health Canada

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