FDA expands recall of heart and blood pressure medicines due to - WSIL-TV 3 Southern Illinois

FDA expands recall of heart and blood pressure medicines due to cancer-causing substance

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UPDATE AUGUST 9, 2018 AT 5:56 P.M.--

WSIL --  The U.S. Food and Drug Administration has updated the list of valsartan products under recall and the list of valsartan products notunder recall to incorporate recalls of valsartan-containing products manufactured by Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals Inc. Not all Camber valsartan products distributed in the U.S. are being recalled.

Camber Pharmaceuticals is recalling certain valsartan tablets because they contain the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API). Hetero Labs manufactures the API for the Camber products using a process similar to Zhejiang Huahai Pharmaceuticals.

ORIGINAL STORY AUGUST 6, 2018 AT 7:05 P.M.--

WSIL -- The U.S. Food and Drug Administration has expanded its voluntary recall of several medications used to treat high blood pressure and heart failure over concerns that an active ingredient in the drugs could be contaminated with a cancer-causing agent.

The agency reported that traces of N-nitrosodimethylamine (NDMA), a "probable human carcinogen," was found in the active ingredient valsartan in the recalled products. The FDA noted not all products containing valsartan are contaminated and being recalled. A third-party supplied the valsartan contained in the recall. The FDA has posted a list of the products recalled. We have posted that list below.

NDMA is classified as a probable human carcinogen -- a substance that could cause cancer -- based on results from laboratory tests. The presence of NDMA is thought to be related to changes in the way the active substance was manufactured. 

-- 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, they should follow the recall instructions provided by the specific company. This information has been 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.

Here is the list of products affected by the recall, as posted by the FDA.

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