Valsartan drug recall in Canada: impurity risk
In plain language
This recall involves Mylan-Valsartan and Teva-Valsartan/HCTZ drugs sold in Canada. They are being recalled because they may contain an impurity called N-nitrosodiethylamine (NDEA) or N-nitrosodimethylamine (NDMA). Continue taking your medication unless advised otherwise by your healthcare provider and contact them to discuss treatment options.
What to do
- Continue taking your valsartan medication unless your healthcare provider advises you to stop.
- Contact your healthcare provider as soon as possible to discuss treatment options.
- Ask your pharmacist if you are unsure whether you are using a recalled product.
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Affected products
MYLAN-VALSARTAN
Model: 02383527 (40 mg), 02383535 (80 mg), 02383543 (160 mg), 02383551 (320 mg)
Lot: All lots
TEVA-VALSARTAN/HCTZ TABLETS
Model: 02356996 (80/12.5 mg), 02357003 (160/12.5 mg), 02357011 (160/25 mg)
Lot: 35211136A, 35211335A, 35211844R
Why this matters
Potential cancer risk from impurity
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 35211136A, 35211335A, 35211844R, All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 02356996 (80/12.5 mg), 02357003 (160/12.5 mg), 02357011 (160/25 mg), 02383527 (40 mg), 02383535 (80 mg), 02383543 (160 mg), 02383551 (320 mg)
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Potential cancer risk from impurity
What should consumers do?
Continue taking your valsartan medication unless your healthcare provider advises you to stop. Contact your healthcare provider as soon as possible to discuss treatment options. Ask your pharmacist if you are unsure whether you are using a recalled product.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Potential cancer risk from impurity
When was this product recalled?
This product was recalled on August 18, 2018.
Is the Mylan, Teva brand affected by this recall?
Yes, Mylan, Teva products are affected by this recall. This recall involves Mylan-Valsartan and Teva-Valsartan/HCTZ drugs sold in Canada. They are being recalled because they may contain an impurity called N-nitrosodiethylamine (NDEA) or N-nitrosodimethylamine (NDMA). Continue taking your medication unless advised otherwise by your healthcare provider and contact them to discuss treatment options.