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fda recall of valsartan

Valsartan Recall

Recent discoveries that generic valsartan may contain deadly contaminants has led to valsartan recalls in the United States and in Europe. Even if made voluntarily, such recalls of the high blood pressure medication are a tacit admission that the drug is defective, and its defects can be the basis of valsartan lawsuits over harmful side effects.

FDA Recall of Generic Valsartan

The U.S. Food and Drug Administration (FDA) called for voluntary recalls of generic valsartan soon after it was learned that some of the products might contain the dangerous cancer-causing element of NDMA, inadvertently introduced by foreign labs during manufacture.

According to the International Agency for Research on Cancer, NDMA can cause cancer in humans. "The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured," the FDA noted in a formal statement.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said the agency has “carefully assessed the valsartan-containing medications sold in the United States” and found that some companies’ products do not meet FDA safety standards.

“This is why we’ve asked these companies to take immediate action to protect patients,”she said. Also, the FDA is continuing an elaborate investigation into generic valsartan products. Twenty-two other nations agree with the FDA’s concerns, having also made their own valsartan recalls. For more discussion of the Valsartan recall history is Valsatan FDA History recall

Don’t Stop Taking Valsartan Immediately

Yet despite these valsartan recalls, the FDA advises patients not to stop taking the drug immediately. Since generic valsartan is prescribed to treat serious medical conditions such as hypertension, the FDA advises that patients who take recalled valsartan products should keep taking them until their physician can provide a substitute drug to meet their health needs.

To hasten the process, patients should contact their physician immediately if they learn their BP medication is part of the valsartan recall.

Generic Valsartan on the Recall List

But which generic valsartan is on the FDA recall list? Major U.S. sellers of generic valsartan involved in the recall include Teva Pharmaceutical, Major Pharmaceuticals and Solco Healthcare.

Also, Torrent Pharmaceuticals Ltd. recalled related products known as valsartan/amlodipine/HCTZ tablets in response to FDA concerns that trace amounts of the impurity NMDA were in the drug. Torrent has recalled 14 lots of its valsartan/amlodipine/HCTZ.

Other valsartan products being recalled, and their sellers, include:

  • Valsartan by Solco Healthcare
  • Valsartan by Major Pharmaceuticals
  • Valsartan by Teva Pharmaceuticals
  • Valsartan/Hydrochlorothiazide (HCTZ) by Teva Pharmaceuticals
  • Valsartan/Hydrochlorothiazide (HCTZ) by Solco Healthcare

And that number is growing. Mylan Pharmaceuticals just announced an expanded recall of valsartan-based products to include all existing lots of the drug that haven’t expired, for a total of 104 lots.

Other manufacturers or suppliers involved in valsartan recalls also include:

  • Actavis
  • A-S Medication Solutions LLC
  • AvKARE
  • Bryant Ranch Prepack Inc.
  • H.J. Harkins Company Inc.
  • Lake Erie Medical, doing business as Quality Care Products LLC
  • NuCare Pharmaceuticals
  • Proficient Rx
  • RemedyRepack

Fears Rise Over Valsartan Side Effects

While such recalls technically may be “voluntary,” rest assured that if the drug suppliers had not made them, mandatory recalls likely would have been ordered by the FDA.

Indeed, public scrutiny and fears of valsartan side effects are rising. The FDA’s online adverse events reporting system has received over 19,000 severe reports -- including over 2,800 deaths -- related to valsartan going back to 2009.

Valsartan Recalls Spur Lawsuits

Valsartan recalls and the very real side effects of stomach cancer, liver cancer or colorectal cancer due to the defective drug are leading to valsartan cancer lawsuits. Such lawsuits can claim payments for victims’ losses, from medical bills to lost salary to pain and suffering.

If you or someone in your family has suffered cancer since taking generic valsartan, notify The Willis Law Firm today. We will quickly provide you with a free and confidential legal review of your case, and we will help you explore your options for a possible BP cancer lawsuit.

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