Are you or a loved one in need of a valsartan lawyer due to the recent recall?

We are accepting certain cases involving patients who have been diagnosed with cancer as a potential side effect of ingesting valsartan. To discuss the specifics of your potential valsartan lawsuit, please contact us for a free and confidential consultation.

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FDA Finds Human Carcinogen In Blood Pressure Medications Containing Valsartan

valsartan lawsuit attorney - van wey lawThe Food and Drug Administration recently announced a voluntary recall of widely-prescribed blood pressure medications containing valsartan over cancer concerns.

Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals USA issued voluntary recalls at the FDA’s request. The recall was made after the FDA reported that a potentially carcinogenic impurity, NDMA (N-nitrosodimethylamine), was found in the drugs.

NDMA is a probable human carcinogen which is a substance that can cause cancer. At this time, the presence of NDMA in valsartan is believed to be caused due to the change in the manufacturing method of the active pharmaceutical ingredient.

 

Which Medications Are Included in the Valsartan Recall?

Recall Date

Brand Name

Product Description

Recall Reason

Company

07/17/2018

Actavis

Valsartan and Valsartan Hydrochlorothiazide Tablets Impurity detected in the API is Nnitrosodimethylamine (NDMA)
Teva Pharmaceuticals USA
07/17/2018
Prinston Pharmaceutical Inc. dba Solco Healthcare LLC Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg Detection of a Trace Amount of Unexpected Impurity, N- nitrosodimethylamine (NDMA) Prinston Pharmaceutical Inc. dba Solco Healthcare LLC
07/13/2018
Major Pharmaceuticals Valsartan tablets, 80mg USP and 160 mg USP May contain the probable carcinogen Nnitrosodimethylamine (NDMA) Major Pharmaceuticals

FDA Action Against Valsartan

The FDA is continuing to review and investigate the levels of NDMA found in medications containing valsartan. In addition, the agency will be investigating and assessing possible effects on patients who have taken the drugs. The FDA is also said to be looking for possible changes to the manufacturing process that will reduce or eliminate the impurity from future batches.

“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” FDA Commissioner Scott Gottlieb, M.D. said.

The Food and Drug Administration recently announced a voluntary recall of widely-prescribed blood pressure medications containing valsartan over cancer concerns.

“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”

The FDA has stressed the importance that patients DO NOT stop taking the recalled products altogether – the danger of abruptly discontinuing use of this medication greatly outweighs the risks associated with short-term NDMA exposure – patients should rather contact their healthcare provider right away to discuss alternative medication options.

Recent Developments

Valsartan

While the investigation is ongoing, there have been several recent developments:

Torrent again expands its voluntary recall of losartan; Hetero also voluntarily recalls losartan

Update [3/1/2019] Torrent Pharmaceuticals Limited is further expanding its voluntary recall to include 114 additional lots of losartan potassium and losartan potassium/hydrochlorothiazide combination tablets. This recall is due to unacceptable amounts of N-Methylnitrosobutyric acid (NMBA) in the losartan active pharmaceutical ingredient manufactured by Hetero Labs Limited.

FDA posts laboratory analysis of NDMA levels in recalled valsartan products

Update [10/5/2018] FDA posted laboratory test results showing NDMA levels in recalled valsartan products. FDA will also post test results and an assessment of the cancer risk from NDEA when they are available.

August 28, 2018 – The initial FDA recall has been expanded to include medications sold by AvKare (Teva/Actavis) and (Hetero/Camber), A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco), Bryant Ranch Prepack Inc. (Teva/Actavis), Hetero Labs (labeled as Camber Pharmaceuticals Inc.), H J Harkins Co., Northwind Pharmaceuticals (Teva/Actavis), NuCare Pharmaceuticals Inc. (Prinston/Solco), Preferred Pharmaceuticals Inc. (Hetero/Camber), Prinston Pharmaceutical Inc. (labeled as Solco Healthcare LLC), Proficient Rx LP, Remedy Repack, Remedy Repack (Prinston/Solco), Remedy Repack Inc. (Hetero/Camber), RemedyRepack Inc. (Torrent), Teva Pharmaceuticals (labeled as Major Pharmaceuticals), Teva Pharmaceuticals USA (labeled as Actavis) and Torrent Pharmaceuticals Limited.

September 27, 2018 – FDA placed Zhejiang Huahai Pharmaceuticals on import alert on September 27, 2018, to protect U.S. patients while the active pharmaceutical ingredient (API) manufacturer fully determines how impurities were introduced into its API and remediates its quality systems. The import alert stops all API made by ZHP and finished drug products made using ZHP’s API from legally entering the United States. FDA’s action follows a recent inspection at ZHP’s facility.

Hiring A Valsartan Lawsuit Attorney

Our attorneys are currently evaluating and investigating claims on behalf of patients who have been diagnosed with cancer as a potential side effect of ingesting a known human carcinogen. If you have been diagnosed with cancer or lost a loved one after ingesting valsartan, please contact us immediately.

In many cases, filing a valsartan lawsuit is the only way to recover money that is lost from hospital expenses, lost wages, and for some – funeral costs. Others file lawsuits because they want to make a difference and prevent others from suffering through the same horrors as they have.

Van Wey Law Can Help, No Matter Where You Live

To discuss the specifics of your potential valsartan lawsuit in a free and confidential consultation, contact us today. You may call us at 1(888)-694-8093.

You can contact Van Wey Law for a free case evaluation to determine if you may be entitled to receive compensation from these irresponsible pharmaceutical companies who place profit over public safety.

By submitting a case evaluation form you will be sent regular Valsartan related updates.