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).
OTTAWA, Aug. 18, 2018 /CNW/ - 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.
A complete list of recalled products is provided below.
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 products that are NOT recalled is provided below.
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.
List of recalled products (products containing the valsartan ingredient from Zhejiang Huahai Pharmaceuticals):
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 ------------------- -------- ------ -------- ------------
List of products that are NOT recalled (products that do NOT contain the valsartan active ingredient from Zhejiang Huahai Pharmaceuticals):
Product name/Active Pharmaceutical Ingredient DIN Strength --------------------------------------------- --- -------- APO-VALSARTAN/HCTZ 02382555 160/12.5 mg ------------------ -------- ----------- APO-VALSARTAN/HCTZ 02382563 160/25 mg ------------------ -------- --------- AURO-VALSARTAN 02414201 40 mg -------------- -------- ----- AURO-VALSARTAN 02414228 80 mg -------------- -------- ----- AURO-VALSARTAN 02414236 160 mg -------------- -------- ------ AURO-VALSARTAN 02414244 320 mg -------------- -------- ------ 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 ------------------ -------- --------- MYLAN-VALSARTAN 02383527 40 mg --------------- -------- ----- MYLAN-VALSARTAN 02383535 80 mg --------------- -------- ----- MYLAN-VALSARTAN 02383551 320 mg --------------- -------- ------ PMS-VALSARTAN 02312999 40 mg ------------- -------- ----- PMS-VALSARTAN 02313006 80 mg ------------- -------- ----- PMS-VALSARTAN 02313014 160 mg ------------- -------- ------ PMS-VALSARTAN 02344564 320 mg ------------- -------- ------ RAN-VALSARTAN 02363062 40 mg ------------- -------- ----- RAN-VALSARTAN 02363100 80 mg ------------- -------- ----- RAN-VALSARTAN 02363119 160 mg ------------- -------- ------ DIOVAN 02270528 40 mg ------ -------- ----- DIOVAN 02289504 320 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 --------------------------------------- -------- ---------
Related Links
- Health Canada advisory (2018-07-09): Several drugs containing valsartan being recalled due to contamination with a potential carcinogen
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SOURCE Health Canada
