Teva Canada expands recall of valsartan drugs to include additional lots, as a precaution

August 18, 2018

OTTAWA – Health Canada is advising Canadians that, as a precautionary measure, Teva Canada is expanding its voluntary recall to include eight additional lots of valsartan products in Canada because they may contain an impurity, N-nitrosodimethylamine (NDMA).

Valsartan is used to treat high blood pressure and heart failure.

This latest action is further to an initial recall of certain valsartan products because of the presence of NDMA in the active ingredient (valsartan). All of the recalled products use a valsartan ingredient manufactured by Zhejiang Huahai Pharmaceuticals in China.

Products containing the valsartan ingredient from Zhejiang Huahai Pharmaceuticals

Health Canada is reviewing the long-term potential health impacts of the NDMA impurity on patients. NDMA is classified as a probable human carcinogen based primarily on animal studies, which means that exposure above acceptable levels over the long term could increase the risk of cancer. The review, which will be completed in the coming weeks, will include an assessment of how much NDMA patients may have been exposed to and for how long. Although Health Canada believes that the NDMA was introduced as a result of a change in manufacturing processes at Zhejiang Huahai Pharmaceuticals in 2012, some Canadian companies may have been using the affected valsartan active ingredient for less time.

The additional Teva Canada products are being recalled after sample testing of the active ingredient by Zhejiang Huahai Pharmaceuticals identified trace levels of NDMA. Testing is ongoing. In the meantime, Health Canada has asked Teva Canada to recall these additional products as a precautionary measure, and to conduct a full investigation to determine the root cause of this most recent issue.

Health Canada is monitoring the recalls. The Department continues to work with the companies and its international regulatory partners to gather and assess information to determine whether additional actions are necessary. We will keep Canadians updated. This includes communicating the results of our health risk assessment once it is complete in the coming weeks.

Products containing valsartan ingredient from other suppliers NOT impacted by the recall

Health Canada has contacted all companies selling valsartan medications in Canada and has confirmed that all of the products NOT being recalled:

• do not contain valsartan manufactured by Zhejiang Huahai Pharmaceuticals, and
• were manufactured using different processes from the ones that have been identified as having introduced the impurity.

Health Canada continues to work with companies selling valsartan medications to determine whether their processes are at risk of producing NDMA.

Health Canada is also working with stakeholders to monitor the Canadian supply of valsartan products and alternative medications.

Reason

A complete list of recalled products is provided below.

A complete list of products that are NOT recalled is provided below.

What you should do

Patients taking affected valsartan medications should:

• Continue taking their valsartan medication unless they have been advised to stop by their health care provider.
• Contact their health care provider as soon as possible to discuss treatment options if they have been using an affected product. Pharmacists may be able to provide a product not affected by the recall, or doctors may prescribe a different medication for their patients’ conditions.
• Ask their pharmacist if they are unsure whether they are using a recalled product.

Health Canada
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