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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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