Blood Pressure Drugs Containing Valsartan Recalled By The FDA | RetailMeNot Rx Saver

A number of pharmaceutical manufacturers are recalling several drug products containing the active ingredient Valsartan. This is due to a detection of trace amounts of N-nitrosodimethylamine (NDMA), which is classified as a probable cause of cancer, according to the Food and Drug Administration.

What is Valsartan?

Valsartan is a moderately priced medication that’s indicative use is for the treatment of hypertension.

What medications are being recalled?

Products containing Valsartan that are being recalled:

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

According to a statement on the FDA’s website, “The exposure to the impurity NDMA that was detected in the Valsartan product line presents an unacceptable carcinogenic risk to the intended patient population.”

What is a carcinogen?

A carcinogen is a substance capable of causing cancer in living tissue.

What to do if your medication is included in the recall

FDA officials say that patients should contact their health care provider – the pharmacist who dispensed their medication or the doctor of whom prescribed it – if their medicine is included in this recall.

The FDA is actively investigating the levels of NDMA in the recalled products. They are also assessing the possible effect on patients that have taken medications containing the substance. Officials are exploring what measures can be taken to reduce or eliminate the impurity from future batches produced by the company. Not all products containing Valsartan are being recalled, according to the FDA.

How do I know if my medication contains Valsartan?

In order to determine if a specific product has been recalled, patients should look at the drug and company name on the label of their prescription bottle, according to the FDA’s website. Patients should contact the pharmacy that dispensed their medicine, if the information is not on the bottle.

“We have carefully assessed the Valsartan-containing medications sold in the United States, and have found that the Valsartan sold by these specific companies does not meet our safety standards,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This is why we’ve asked these companies to take immediate action to protect patients.”

The FDA posts the company’s announcement as a public service, whenever a recall, market withdrawal, or safety alert is posted. For more information related to the recall, visit the FDA’s website.

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