Health Canada announced the expanded recall on Sunday, after testing identified traces of the impurity in products from Teva Canada. Teva is among the top five Canadian pharmaceutical companies in annual sales.
Valsartan is used to treat patients with blood pressure issues, as well as those who have recently suffered a heart attack or heart failure.
The affected medication may contain traces of N-nitrosodimethylamine (NDMA), a “probable human carcinogen” that could increase the risk of cancer through long-term exposure above acceptable levels, Health Canada says.
Anyone who takes valsartan is encouraged to continue doing so, unless instructed otherwise by a health-care provider, Health Canada says. Individuals using a recalled product are urged to get in touch with their doctor to discuss treatment options, as there are still a number of valsartan products not affected by the recall.
The recalled drugs were supplied by Zhejiang Huahai Pharmaceuticals, a Chinese company that ships valsartan to more than a dozen countries.
Health Canada says the impurities were likely introduced when the manufacturing process was changed in 2012, although some Canadian companies may have been using the affected products for less time.
The U.S. Food and Drug Administration (FDA) expanded its own recall of valsartan drugs earlier this month to include products made at a facility in India. The FDA said the Indian facility was producing valsartan “using a process similar to Zhejiang Huahai Pharmaceuticals.”
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Officials at Health Canada say they’ve been in touch will all Canadian valsartan suppliers, and that several products remain unaffected by the impurity issue.
A full list of unaffected products can be found on Health Canada’s website.
The newly-recalled Teva Canada drugs are listed below. For a full list of recalled valsartan medications, visit Health Canada’s website:
- TEVA-VALSARTAN/HCTZ TABLETS 80/12.5 MG, DIN 02356996, LOT 35211136A
- TEVA-VALSARTAN/HCTZ TABLETS 160/12.5 MG, DIN 02357003, LOT 35211335A
- TEVA-VALSARTAN/HCTZ TABLETS 160/25 MG, DIN 02357003, 35211844R
- TEVA-VALSARTAN/HCTZ TABLETS 160/25 MG, DIN 02357011, 35210937R
- TEVA-VALSARTAN/HCTZ TABLETS 160/25 MG, DIN 02357011, LOT 35210938R
- TEVA-VALSARTAN/HCTZ TABLETS 160/25 MG, DIN 02357011, LOT 35210939R
- TEVA-VALSARTAN/HCTZ TABLETS 160/25 MG, DIN 02357011, LOT 35210940R
- TEVA-VALSARTAN/HCTZ TABLETS 320/12.5 MG, DIN 02357038, LOT 35211546R