Valsartan Class Action

UPDATE

September 13, 2018

We are aware of the reports that a second probable carcinogen, NDEA, has been found in the recalled valsartan medication according to Health Canada. We are investigating and we will provide you with an update as soon as possible.

For more information, please review the following:

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67746a-eng.php

https://www.cbc.ca/news/health/valsartan-impurity-ndea-1.4822062

https://globalnews.ca/news/4445643/valsartan-blood-pressure-carcinogen-recall/

August 20, 2018

 If your physician or pharmacist has switched you over to a non-recalled blood pressure medication, we recommend that you keep any leftover recalled valsartan pills stored in a safe place for the purposes of this litigation, if possible and cost-permissive.

THE RECALL

According to a bulletin issued by Health Canada on July 9, 2018, several varieties of valsartan, a common blood pressure drug sold by several pharmaceutical companies in Canada, are being recalled. The bulletin can be accessed in English here: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67202a-eng.php, and in French here: http://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67202a-fra.php.

Health Canada said on Tuesday July 9, 2018, that numerous varieties of valsartan are being recalled over fears they contain the impurity NDMA, a chemical that’s been classified as a probable human carcinogen by the International Agency for Research on Cancer.

In a public advisory, Health Canada said Chinese Company Zhejiang Huahai Pharmaceutical supplied valsartan to several companies that used it to make the finished product.

The director of the Food and Drug Administration's (the "FDA", which is the Federal agency in the United States that regulates all drug manufacturers and pharmaceutical products) Center for Drug Evaluation and Research, Dr. Janet Woodcock, said "We have carefully assessed the valsartan-containing medications sold in the United States, and we've found that the valsartan sold by these specific companies does not meet our safety standards. This is why we've asked these companies to take immediate action to protect patients."

Dr. Erin Michos, an associate professor and associate director of preventive cardiology at John Hopkins University, spoke to the US news agency CNN about the health risks from exposure to NDMA:

“As of now, the long-term risks posed by the NDMA found in certain valsartan-containing drugs remain somewhat unknown, and the amount of NDMA consumed would play a role in those risks, Michos said. In other words, ‘the dose makes the poison,’ she said.” 

The CNN article can be read here: https://www.cnn.com/2018/07/19/health/valsartan-recall-explainer/index.html

If you or a loved one has been prescribed one of the lots of the valsartan drugs described in the list below, you may be entitled to compensation. If so, please contact Dora Konomi at Charney Lawyers by email:  dkonomi@charneylawyers.com.

A press release, dated July 13, 2018, stating that a proposed class action has been commenced with respect to the recall can be viewed here.

Health Canada has provided the following list of affected drugs subject to the recall:

Product name/Active Pharmaceutical Ingredient DIN Strength Lot # Date added
TEVA-VALSARTAN/HCTZ TABLETS 02356996 80/12.5 mg 35211136A August 17, 2018
TEVA-VALSARTAN/HCTZ TABLETS 02357003 160/12.5 mg 35211335A August 17, 2018
TEVA-VALSARTAN/HCTZ TABLETS 02357003 160/12.5 mg 35211844R August 17, 2018
TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210937R August 17, 2018
TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210938R August 17, 2018
TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210939R August 17, 2018
TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210940R August 17, 2018
TEVA-VALSARTAN/HCTZ TABLETS 02357038 320/12.5 mg 35211546R August 17, 2018
TEVA-VALSARTAN/HCTZ TABLETS PP 30s 02357046 320/25 mg 35212731R July 9, 2018
ACT-VALSARTAN 40MG FC TABLETS 100 02337487 40 mg K47338 July 9, 2018
ACT-VALSARTAN 80MG FC TABLETS 100 02337495 80 mg K45370 July 9, 2018
ACT-VALSARTAN 80MG FC TABLETS 100 02337495 80 mg K47652 July 9, 2018
ACT-VALSARTAN 80MG FC TABLETS 100 02337495 80 mg K47653 July 9, 2018
ACT-VALSARTAN 80MG FC TABLETS 100 02337495 80mg K47654 July 9, 2018
ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K39691 July 9, 2018
ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K44167 July 9, 2018
ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K47657 July 9, 2018
ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K47658 July 9, 2018
ACT-VALSARTAN 320MG FC TABLETS 100 02337517 320 mg K44166 July 9, 2018
ACT-VALSARTAN 320MG FC TABLETS 100 02337517 320 mg K45371 July 9, 2018
SANDOZ VALSARTAN 40 MG 02356740 40 mg All lots July 9, 2018
SANDOZ VALSARTAN 80 MG 02356759 80 mg All lots July 9, 2018
SANDOZ VALSARTAN 160 MG 02356767 160 mg All lots July 9, 2018
SANDOZ VALSARTAN 320 MG 02356775 320 mg All lots July 9, 2018
SANIS VALSARTAN 40 MG 02366940 40 mg All lots July 9, 2018
SANIS VALSARTAN 80 MG 02366959 80 mg All lots July 9, 2018
SANIS VALSARTAN 160 MG 02366967 160 mg All lots July 9, 2018
SANIS VALSARTAN 320 MG 02366975 320 mg All lots July 9, 2018
PRO DOC LIMITEE VALSARTAN 40 MG 02367726 40 mg All lots July 9, 2018
PRO DOC LIMITEE VALSARTAN 80 MG 02367734 80 mg All lots July 9, 2018
PRO DOC LIMITEE VALSARTAN 160 MG 02367742 160 mg All lots July 9, 2018
PRO DOC LIMITEE VALSARTAN 320 MG 02367750 320 mg All lots July 9, 2018
SIVEM PHARMACEUTICAL ULC VALSARTAN 40 MG 02384523 40 mg All lots July 9, 2018
SIVEM PHARMACEUTICAL ULC VALSARTAN 80 MG 02384531 80 mg All lots July 9, 2018
SIVEM PHARMACEUTICAL ULC VALSARTAN 160 MG 02384558 160 mg All lots July 9, 2018
SIVEM PHARMACEUTICAL ULC VALSARTAN 320 MG 02384566 320 mg All lots July 9, 2018

UPDATES

(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.

Source: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67552a-eng.php

 

Below are links to media reports on the recall:

https://www.theglobeandmail.com/canada/article-health-canada-recalls-blood-pressure-drug-valsartan-after-carcinogenic/

https://globalnews.ca/news/4322539/valsartan-drug-recall-canada/

https://www.cbc.ca/news/health/valsartan-heart-high-blood-pressure-medication-recall-1.4740666

https://www.cp24.com/lifestyle/health/health-canada-recalls-some-drugs-containing-valsartan-due-to-potential-carcinogen-1.4007325

https://www.ctvnews.ca/health/common-heart-drugs-recalled-due-to-contamination-with-possible-carcinogen-1.4007298

https://www.cnn.com/2018/07/13/health/valsartan-recall-fda-bn/index.html

If you are taking any of the medications on this list, please REGISTER HERE to receive updates about the class action.

You can also contact Charney Lawyers by email: dkonomi@charneylawyers.com

 

Register Here

If you are taking any medications on the list of affected drugs containing valsartan, by clicking the button on the right:

Learn more about Charney Lawyers at www.charneylawyers.com