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Update - Advisory - Several drugs containing valsartan being recalled due to contamination with a potential carcinogen
 
(July 10, 2018)

 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.

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

Également disponible en français

 

SOURCE Health Canada

Copyright 2014 PR Newswire. All Rights Reserved


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