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

Published: Jul 10, 2018

OTTAWA, July 9, 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
      ---------------------------      -------- --------- ---------

      TEVA-VALSARTAN/HCTZ TABLETS
                 (Bulk)                02357046 320/25 mg           35212732
      ---------------------------      -------- ---------           --------

         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
        ----------------------         --------   ------  --------

     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.

Stay connected with Health Canada and receive the latest advisories and product recalls.

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SOURCE Health Canada

 

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