August 18, 2018
OTTAWA – Health Canada is 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).
Valsartan is used to treat high blood pressure and heart failure.
This latest action is further to an initial recall of certain valsartan products because of the presence of NDMA in the active ingredient (valsartan). All of the recalled products use a valsartan ingredient manufactured by Zhejiang Huahai Pharmaceuticals in China.
Products containing the valsartan ingredient from Zhejiang Huahai Pharmaceuticals
Health Canada is reviewing the long-term potential health impacts of the NDMA impurity on patients. NDMA is classified as a probable human carcinogen based primarily on animal studies, which means that exposure above acceptable levels over the long term could increase the risk of cancer. The review, which will be completed in the coming weeks, will include an assessment of how much NDMA patients may have been exposed to and for how long. Although Health Canada believes that the NDMA was introduced as a result of a change in manufacturing processes at Zhejiang Huahai Pharmaceuticals in 2012, some Canadian companies may have been using the affected valsartan active ingredient for less time.
The additional Teva Canada products are being recalled after sample testing of the active ingredient by Zhejiang Huahai Pharmaceuticals identified trace levels of NDMA. Testing is ongoing. In the meantime, Health Canada has asked Teva Canada to recall these additional products as a precautionary measure, and to conduct a full investigation to determine the root cause of this most recent issue.
Health Canada is monitoring the recalls. The Department continues to work with the companies and its international regulatory partners to gather and assess information to determine whether additional actions are necessary. We will keep Canadians updated. This includes communicating the results of our health risk assessment once it is complete in the coming weeks.
Products containing valsartan ingredient from other suppliers NOT impacted by the recall
Health Canada has contacted all companies selling valsartan medications in Canada and has confirmed that all of the products NOT being recalled:
- do not contain valsartan manufactured by Zhejiang Huahai Pharmaceuticals, and
- were manufactured using different processes from the ones that have been identified as having introduced the impurity.
Health Canada continues to work with companies selling valsartan medications to determine whether their processes are at risk of producing NDMA.
Health Canada is also working with stakeholders to monitor the Canadian supply of valsartan products and alternative medications.
A complete list of recalled products is provided below.
|Product name/Active Pharmaceutical Ingredient||DIN||Strength||Lot #||Date added|
|TEVA-VALSARTAN/HCTZ TABLETS||02356996||80/12.5 mg||35211136A||August 17, 2018|
|TEVA-VALSARTAN/HCTZ TABLETS||02357003||160/12.5 mg||35211335A||August 17, 2018|
|TEVA-VALSARTAN/HCTZ TABLETS||02357003||160/12.5 mg||35211844R||August 17, 2018|
|TEVA-VALSARTAN/HCTZ TABLETS||02357011||160/25 mg||35210937R||August 17, 2018|
|TEVA-VALSARTAN/HCTZ TABLETS||02357011||160/25 mg||35210938R||August 17, 2018|
|TEVA-VALSARTAN/HCTZ TABLETS||02357011||160/25 mg||35210939R||August 17, 2018|
|TEVA-VALSARTAN/HCTZ TABLETS||02357011||160/25 mg||35210940R||August 17, 2018|
|TEVA-VALSARTAN/HCTZ TABLETS||02357038||320/12.5 mg||35211546R||August 17, 2018|
|TEVA-VALSARTAN/HCTZ TABLETS PP 30s||02357046||320/25 mg||35212731R||July 9, 2018|
|ACT-VALSARTAN 40MG FC TABLETS 100||02337487||40 mg||K47338||July 9, 2018|
|ACT-VALSARTAN 80MG FC TABLETS 100||02337495||80 mg||K45370||July 9, 2018|
|ACT-VALSARTAN 80MG FC TABLETS 100||02337495||80 mg||K47652||July 9, 2018|
|ACT-VALSARTAN 80MG FC TABLETS 100||02337495||80 mg||K47653||July 9, 2018|
|ACT-VALSARTAN 80MG FC TABLETS 100||02337495||80mg||K47654||July 9, 2018|
|ACT-VALSARTAN 160MG FC TABLETS 100||02337509||160 mg||K39691||July 9, 2018|
|ACT-VALSARTAN 160MG FC TABLETS 100||02337509||160 mg||K44167||July 9, 2018|
|ACT-VALSARTAN 160MG FC TABLETS 100||02337509||160 mg||K47657||July 9, 2018|
|ACT-VALSARTAN 160MG FC TABLETS 100||02337509||160 mg||K47658||July 9, 2018|
|ACT-VALSARTAN 320MG FC TABLETS 100||02337517||320 mg||K44166||July 9, 2018|
|ACT-VALSARTAN 320MG FC TABLETS 100||02337517||320 mg||K45371||July 9, 2018|
|SANDOZ VALSARTAN 40 MG||02356740||40 mg||All lots||July 9, 2018|
|SANDOZ VALSARTAN 80 MG||02356759||80 mg||All lots||July 9, 2018|
|SANDOZ VALSARTAN 160 MG||02356767||160 mg||All lots||July 9, 2018|
|SANDOZ VALSARTAN 320 MG||02356775||320 mg||All lots||July 9, 2018|
|SANIS VALSARTAN 40 MG||02366940||40 mg||All lots||July 9, 2018|
|SANIS VALSARTAN 80 MG||02366959||80 mg||All lots||July 9, 2018|
|SANIS VALSARTAN 160 MG||02366967||160 mg||All lots||July 9, 2018|
|SANIS VALSARTAN 320 MG||02366975||320 mg||All lots||July 9, 2018|
|PRO DOC LIMITEE VALSARTAN 40 MG||02367726||40 mg||All lots||July 9, 2018|
|PRO DOC LIMITEE VALSARTAN 80 MG||02367734||80 mg||All lots||July 9, 2018|
|PRO DOC LIMITEE VALSARTAN 160 MG||02367742||160 mg||All lots||July 9, 2018|
|PRO DOC LIMITEE VALSARTAN 320 MG||02367750||320 mg||All lots||July 9, 2018|
|SIVEM PHARMACEUTICAL ULC VALSARTAN 40 MG||02384523||40 mg||All lots||July 9, 2018|
|SIVEM PHARMACEUTICAL ULC VALSARTAN 80 MG||02384531||80 mg||All lots||July 9, 2018|
|SIVEM PHARMACEUTICAL ULC VALSARTAN 160 MG||02384558||160 mg||All lots||July 9, 2018|
|SIVEM PHARMACEUTICAL ULC VALSARTAN 320 MG||02384566||320 mg||All lots||July 9, 2018|
A complete list of products that are NOT recalled is provided below.
|Product name/Active Pharmaceutical Ingredient||DIN||Strength|
|AURO-VALSARTAN HCT||02408112||80/12.5 mg|
|AURO-VALSARTAN HCT||02408120||160/12.5 mg|
|AURO-VALSARTAN HCT||02408139||160/25 mg|
|AURO-VALSARTAN HCT||02408147||320/12.5 mg|
|AURO-VALSARTAN HCT||02408155||320/25 mg|
|DIOVAN VALSARTAN||02236809||160 mg|
|DIOVAN VALSARTAN||02244782||160 mg|
|DIOVAN VALSARTAN||02236808||80 mg|
|DIOVAN VALSARTAN||02244781||80 mg|
|DIOVAN VALSARTAN HCT||02241900||80/12.5 mg|
|DIOVAN VALSARTAN HCT||02241901||160/12.5 mg|
|DIOVAN VALSARTAN HCT||02246955||160/25 mg|
|DIOVAN VALSARTAN HCT||02308908||320 mg|
|SANDOZ VALSARTAN HCT||02356694||80/12.5 mg|
|SANDOZ VALSARTAN HCT||02356708||160/12.5 mg|
|SANDOZ VALSARTAN HCT||02356716||160/25 mg|
|SANDOZ VALSARTAN HCT||02356724||320/12.5 mg|
|SANDOZ VALSARTAN HCT||02356732||320/25 mg|
|SANIS VALSARTAN HCT||02367009||80/12.5 mg|
|SANIS VALSARTAN HCT||02367017||160/12.5 mg|
|SANIS VALSARTAN HCT||02367025||160/25 mg|
|SANIS VALSARTAN HCT||02367033||320/12.5 mg|
|SANIS VALSARTAN HCT||02367041||320/25 mg|
|SIVEM PHARMACEUTICALS ULC VALSARTAN HCT||02384736||80/12.5 mg|
|SIVEM PHARMACEUTICALS ULC VALSARTAN HCT||02384744||160/12.5 mg|
|SIVEM PHARMACEUTICALS ULC VALSARTAN HCT||02384752||160/25 mg|
|SIVEM PHARMACEUTICALS ULC VALSARTAN HCT||02384760||320/12.5 mg|
|SIVEM PHARMACEUTICALS ULC VALSARTAN HCT||02384779||320/25 mg|
What you should do
Patients taking affected valsartan medications should:
- Continue taking their valsartan medication unless they have been advised to stop by their health care provider.
- Contact their health care provider as soon as possible to discuss treatment options if they have been using an affected product. Pharmacists may be able to provide a product not affected by the recall, or doctors may prescribe a different medication for their patients’ conditions.
- Ask their pharmacist if they are unsure whether they are using a recalled product.