Mylan-Valsartan recall in Canada: impurity may increase cancer risk
In plain language
This recall involves Mylan-Valsartan tablets sold in Canada. They are being recalled because testing found low levels of an impurity, N-nitrosodiethylamine (NDEA), which is a probable human carcinogen. Do not stop taking your medication unless advised by your healthcare provider and contact them to discuss treatment options.
What to do
- Continue taking your valsartan medication unless advised to stop by your healthcare provider.
- Contact your healthcare provider to discuss treatment options if you have been using an affected product.
- Ask your pharmacist if you are unsure whether you are taking a recalled product.
- Contact Mylan at 1-800-575-1379 or recall@mylan.ca if you have questions.
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Affected products
MYLAN-Valsartan 40 mg
Lot: 3048813-1
MYLAN-Valsartan 80 mg
Lot: 3056368
MYLAN-Valsartan 160 mg
Lot: 3056371
MYLAN-Valsartan 320 mg
Lot: 3048815-1
Why this matters
Increased cancer risk due to 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: 3048813-1, 3048815-1, 3056368, 3056371
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?
Increased cancer risk due to impurity
What should consumers do?
Continue taking your valsartan medication unless advised to stop by your healthcare provider. Contact your healthcare provider to discuss treatment options if you have been using an affected product. Ask your pharmacist if you are unsure whether you are taking a recalled product. Contact Mylan at 1-800-575-1379 or recall@mylan.ca if you have questions.
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. Increased cancer risk due to impurity
When was this product recalled?
This product was recalled on November 28, 2018.
Is the Mylan brand affected by this recall?
Yes, Mylan products are affected by this recall. This recall involves Mylan-Valsartan tablets sold in Canada. They are being recalled because testing found low levels of an impurity, N-nitrosodiethylamine (NDEA), which is a probable human carcinogen. Do not stop taking your medication unless advised by your healthcare provider and contact them to discuss treatment options.