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Valsartan-Containing Drugs Recalled Due to Possible Carcinogenic Impurities

Valsartan Drug Recall

Valsartan Drug Recall

The voluntary recall of valsartan-containing medications has recently been expanded to now include drugs made by nine different pharmaceutical companies.1

First announced on July 13th, this recall was triggered by findings of that some valsartan-containing drugs may have been contaminated by a substance associated with an increased cancer risk.

This substance, n-nitrosodimethylamine (NDMA), has been deemed to be a potential carcinogenic by authorities at the U.S. Environmental Protection Agency (EPA).2

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Background on Valsartan & the Recall

Valsartan is an active ingredient in various types of medications prescribed to treat high blood pressure and heart failure. The valsartan-containing medications impacted by the recall and suspected to be potentially contaminated by NDMA have all reportedly been supplied by Zhejiang Huahai Pharmaceuticals (ZHP), based in China.

ZHP has explained that the possibility for valsartan contamination was entirely unexpected. While the company has yet to identify the precise cause, it has explained that changes in how the company manufactures valsartan are thought to have played a role in introducing the NDMA impurities.

According to FDA authorities, “based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-containing products for as long as four years.”1

More on the Valsartan Recall: What Consumers Must Know

  • The pharmaceutical companies – The nine drug companies that have launched the voluntary valsartan drug recall include Teva Pharmaceuticals (labeled as Major Pharmaceuticals and Actavis); Prinston Pharmaceuticals, Inc. (labeled as Solco Healthcare, LLC); AvKARE; Remedy Repack; Bryant Ranch Prepack, Inc.; H J Harkins Company; Northwind Pharmaceuticals; Proficient Rx LP; and A-S Medication Solutions, LLC.
  • The list of recalled drugs – The 35 different valsartan-containing drugs that have been impacted by this recall (as of August 2018) are listed here, along with the specific lot numbers and National Drug Codes (NDCs) associated with each.
  • What to do if you’re taking a medication containing valsartan – Crosscheck your medication’s label information with recall info to determine if your medications are affected by the recall (please note that not all valsartan-containing drugs are included in this recall). If you are unsure about whether your medication has been recalled, contact your pharmacist for additional help. If your medication is among the recalled lots, contact your pharmacist and/or physician for assistance finding a safe alternative.

FDA Investigation into Contaminated Valsartan Is Ongoing

As the FDA continues to oversee this recall and conduct further investigations, it is actively evaluating the possible impacts that contaminated valsartan-containing drugs may have on patients, as well as what can be done to minimize the risk of future drug contamination.

Commenting on this recall and the FDA’s ongoing role in it, the FDA’s Director of the Center for Drug Evaluation and Research, Janet Woodcock, M.D., has stated:

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.

FDA Commissioner Scott Gottlieb, M.D. backed up these statements, explaining that:

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… 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.

Have You Been Harmed By a Valsartan-Containing Drug? Contact a Dangerous Drug Lawyer at the Amaro Law Firm

A dangerous drug lawyer at the Amaro Law Firm is ready to help you get on the path to recovery and justice if you or a loved one has been seriously harmed by contaminated valsartan or any risky medication.

Call (877) 892-2797 or email our firm for your FREE, no obligations consultation.

Empowered with more than 20 years of legal experience, our attorneys have the insight, skills and resources you can count on for exceptional advocacy as we help you successfully navigate the recovery process. We are highly experienced at standing up to negligent pharmaceutical companies and others, and we will diligently and tirelessly advocate on behalf of our clients to help them:

  • Hold negligent parties liable
  • Obtain the full compensation they deserve for their drug-related injuries, suffering and losses.

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1: FDA Information on the Valsartan Recall
2: EPA Fact Sheet on NDMA