Drugs containing valsartan being recalled due to contamination with potential carcinogen
Update - August 18, 2018
Further to the initial recall of certain valsartan products because of the presence of NDMA in the active ingredient, Health Canada is now advising Canadians that, as a precautionary measure, Teva Canada is expanding its voluntary recall to include eight additional lots of valsartan products in Canada because they may contain an impurity, N-nitrosodimethylamine (NDMA).
July 10, 2018
Health Canada has issued a recall for several drugs containing valsartan due to contamination with potential carcinogen.
Drugs containing valsartan are used to treat patients with high blood pressure to help prevent heart attacks and stroke as well as patients who have had heart failure or a recent heart attack.
Patients are advised to keep taking their medicine until they talk with their pharmacist or primary care provider to determine if their medication is affected.
Pharmacists and primary care providers will work together with patients who are affected to help them safely transition to an alternative medication.
Pharmacists can provide recommendations for safe therapeutic alternatives and provide therapeutic substitutions as needed (following the requirements under Professional Practice Policy-58: Medication Management (Adapting a Prescription)).
For practice support related to the recall, questions can be directed to:
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.
The following products have been affected:
|TEVA-VALSARTAN/HCTZ TABLETS||02356996||80/12.5 mg||35211136A|
|TEVA-VALSARTAN/HCTZ TABLETS||02357003||160/12.5 mg||35211335A|
|TEVA-VALSARTAN/HCTZ TABLETS||02357003||160/12.5 mg||35211844R|
|TEVA-VALSARTAN/HCTZ TABLETS||02357011||160/25 mg||35210937R|
|TEVA-VALSARTAN/HCTZ TABLETS||02357011||160/25 mg||35210938R|
|TEVA-VALSARTAN/HCTZ TABLETS||02357011||160/25 mg||35210939R|
|TEVA-VALSARTAN/HCTZ TABLETS||02357011||160/25 mg||35210940R|
|TEVA-VALSARTAN/HCTZ TABLETS||02357038||320/12.5 mg||35211546R|
|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|
Advice for Patients
- 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 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.
The recall affects up to 90% of single-molecule valsartan products. Except for TEVA-Valsartan/HCTZ 320/25mg (DIN 02357046), most formulations of valsartan-hydrochlorothiazide are not affected by the recall.
Pharmacy Recall Procedures
Pharmacies should use their standard corporate recall processes to identify and inform patients who currently have a supply of any of the affected lot numbers or DINs. Patients should be requested to replace their existing supply as soon as possible.
Reference Drug Program
- See more information on the Reference Drug Program (for the public)
- See more information on the Reference Drug Program (for practitioners)
As with any RDP drug, pharmacists may switch patients to another product within the RDP category if such a switch would be beneficial to the patient, allowable under the College of Pharmacists Professional Practice Policy 58, and result in a lower (or same) cost to PharmaCare.
Due to the nature of the valsartan recall, pharmacists may encounter patients eager to switch their medication. Please refer to:
- College of Pharmacists of BC Professional Practice Policy-58:Medication Management (Adapting a Prescription) and Orientation Guide / Amendment / Quick Reference / FAQs to determine if a patient can be switched to a different angiotensin receptor blocker;
- current RDP and LCA data files for PharmaCare coverage information
- Decision Tree for Switching Drugs: Angiotensin Receptor Blockers (ARBs)