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Informational update. Milan-Valsartan medicines voluntarily recalled as a precautionary measure due to impurities



OTTAWA, November 28, 2018/ CNW / –

Release:
Mylan Pharmaceuticals ULC voluntarily withdrew four batches of Milan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg) after testing, low levels of impurities, N-nitrosodiethylamine (NDEA), were detected.

Valsartan – a drug Used to treat patients with high blood pressure to prevent heart attacks and strokes. It is also used in patients with heart failure or a recent heart attack.

Products withdrawn as a precaution. Although levels of NDEA are found in the active pharmaceutical ingredient (valsartan), which is manufactured by Mylan Laboratories Limited in Indiaare low, they are above what is considered reasonably safe if the drug was taken throughout life. Given that the affected products were on the Canadian market, this review is taken with an abundance of caution.

This latest review also applies to recent reviews and other actions taken in Canada and internationally, as a result of NDEA and other N-nitrosodimethylamine (NDMA) impurities found in some preparations (see the links below for relevant messages). Both NDEA and NDMA are classified as probable human carcinogens, which means that long-term exposure may increase the risk of developing cancer.

Health Canada continues to work with companies and international regulatory partners to determine the extent and root cause of the problem, and to confirm that necessary measures are being taken to eliminate it and prevent recurrence. The department will follow these reviews. If additional security issues are identified, Health Canada will take appropriate action and continue to inform Canadians.

Disadvantages are not expected as a result of this recall, since alternative products exist on the Canadian market. As in previous reports regarding NDEA and NDMA, Health Canada reports that there is no immediate risk for patients taking these drugs, since the risk of cancer is associated with the long-term effects of these contaminants. Patients should not stop taking medications unless they have advised them to a health care provider.

What should consumers do

  • Continue to take your valsartan medication. if a you are advised to stay with your health care provider.
  • Contact your health care provider to discuss treatment options if you are using an affected product.
  • Ask your pharmacist if you are not sure whether you are accepting a withdrawn product.
  • Contact your doctor if you have taken a withdrawn product and you have concerns about your health.
  • Contact Mylan by phone at 1-800-575-1379 or by e-mail remind@mylan.ca if you have questions about the recall.
  • Report any side effects or health complaints related to drugs to Health Canada.

Affected Products

The following products of Mailan Valsartan are recalled.

(Note: A related list of other valsartan products that have been and have not been withdrawn is available in this previous notice.)

Product Name / Active
Pharmaceutical ingredient

Strength

DIN

Lot

Mylan-Valsartan

40 mg

02383527

3048813-1

Mylan-Valsartan

80 mg

02383535

3056368

Mylan-Valsartan

160 mg

02383543

3056371

Mylan-Valsartan

320 mg

02383551

3048815-1

Related Links

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SOURCE Health Canada


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