Notice – Several drugs containing valsartan are recalled due to contamination with a potential carcinogen



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OTTAWA July 9, 2018 / CNW / –

Version: Several manufacturers of the valsartan ingredient are recalled by their manufacturers. An impurity, N-nitrosodimethylamine (NDMA), has been found in valsartan used in these products. Valsartan was supplied by Zhejiang Huahai Pharmaceuticals. NDMA is a potential carcinogen to humans, which means that it could cause cancer with long-term exposure. Five companies assigned products that are recalled (identified in the table below).

Drugs containing valsartan are used to treat patients with high blood pressure to prevent heart attacks and strokes. These drugs are also used in patients who have had heart failure or a recent heart attack.

Who is affected

  • Consumers who use valsartan products in the table below.

Products Affected

[19659008] Product Name / Active Pharmaceutical Ingredient

DIN

Resistance

Batch No.

TABLETS TEVA-VALSARTAN / HCTZ PP 30s

02357046

320/25 mg

35212731R

TABLETS OF TEVA-VALSARTAN / HCTZ (bulk)

02357046

320/25 mg

35212732

TABLETS ACT-VALSARTAN 40MG FC 100

02337487

40mg

K47338

ACT-VALSARTAN 80MG FC TABLETS 100

02337495

80mg

K45370

ACT-VALSARTAN 80MG FC COMPRESSED 100

02337495

80mg

K47652

ACT-VALSARTAN 80MG FC TABLETS 100

02337495

80mg

K47653

ACT-VALSARTAN 80MG FC COMPRESSED 100

02337495

80mg

K47654 [19659016] ACT-VALSARTAN 160MG FC COMPRESSED 100

02337509

160 mg

K39691

ACT-VA LSARTAN 160MG FC TABLETS 100

02337509

160 mg

K44167

ACT-VALSARTAN 160MG FC TABLETS 100

02337509

160 mg

K47657

ACT-VALSARTAN 160MG FC TABLETS

02337509

160mg

K47658

ACT-VALSARTAN 320MG FC TABLETS 100

02337517

320mg

K44166

ACT-VALSARTAN 320MG FC TABLETS 100

02337517

320 mg

K45371

SANDOZ VALSARTAN 40 MG

02356740 [19659013] 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

0236 6959

80 mg

All lots

SANIS VALSARTAN 160 MG

02366967

160 mg

All lots

PRO LIMITED DOCTOR VALSARTAN 40 MG

02367726

40 mg

All lots

DOC LIMITED LIMITEE VALSARTAN 80 MG

02367734

80 mg

All lots

PRO DOC LIMITED VALSARTAN 160 MG

02367742

160 mg

All lots

PRO LIMITED DOCTOR 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 your doctor or pharmacist tells you to take it stop you.
  • If you are taking a medicine containing valsartan, talk to your pharmacist who can tell you if your medicine has been recalled.
  • If you have used an affected product, contact your healthcare professional as soon as possible to discuss your treatment options.
  • If you are in a clinical phase with a product containing valsartan and have questions, talk to
  • Report side effects (side effects) of health products to Health Canada by calling toll-free 1- 866-234-2345 or by filing an online, mail or fax
  • health products submission to Health Canada by calling toll free at 1-800-267-9675, or by completing a complaint form. line.

What Health Canada

  • Health Canada Monitors Business Recalls If other safety information is identified, Health Canada will take appropriate action and inform Canadians [19659131] Stay in touch with Health Canada and receive the latest product alerts and recalls.

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    SOURCE Health Canada

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