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July 13, 2018: FDA Announces Valsartan Recall Due To Detection Of Impurity

Detection Of Impurity Prompts Valsartan Recall

On July 13, 2018, the FDA alerted health care professionals and patients of a recall for multiple drug products containing the active pharmaceutical ingredient, valsartan, because the products contained an impurity known as N-nitrosodimethylamine (NDMA). Not all products containing valsartan are subject to the valsartan recall. The FDA cautioned that “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.”

Valsartan Recall Information for Patients and Health Care Professionals

Valsartan is prescribed to treat high blood pressure and heart failure. The FDA has provided health care professional and the public with the following safety information. Patients should neither start nor stop taking any medication, including medications containing valsartan, without consulting their health care professional.

“• Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.

• To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.

• If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website.

• Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.”

Valsartan Recall – Product Information

The FDA reports that the companies listed below are recalling all lots of non-expired products that contain valsartan supplied by Zhejiang Huahai Pharmaceuticals of Linhai, China. (See FDA Recalls for the most up-to-date valsartan recall list.)

Major Pharmaceuticals (Valsartan)
Solco Healthcare (Valsartan)
Teva Pharmaceuticals Industries Ltd. (Valsartan)
Solco Healthcare [Valsartan/Hydrochlorothiazide (HCTZ)]
Teva Pharmaceuticals Industries Ltd. [Valsartan/Hydrochlorothiazide (HCTZ)]

Not all valsartan medications distributed in the US contain valsartan active pharmaceutical ingredient (API) supplied by Zhejiang Huahai Pharmaceuticals. The FDA also reported that Zhejiang Huahai has stopped distributing its valsartan API, and that the agency is working with companies affected by the valsartan recall to reduce or eliminate the valsartan API impurity from future products.

FDA Investigation Is Ongoing

The FDA continues to review the levels of NDMA in the recalled products, assess the possible effect on patients who have been taking them, and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company. Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research stated in the FDA News Release that “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”.

The agency encourages patients and health care professionals to report any adverse drug reactions to the FDA’s MedWatch Program.

Drug Side Effect Legal Help

Attorney Eric H. Weinberg has assisted those injured by defective medications and medical devices since 1984. If you or a loved one has been injured by a defective or dangerous drug product, and you would like more information regarding your legal rights, please call our firm toll free at 1-877-834-6274, or submit the easy-to-use free legal case evaluation form found on this page.

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