FDA expands recall of blood pressure drugs due to cancer-causing impurity

elderly woman in hospital bed pulseox sensor SMALL FDA expands recall of blood pressure drugs due to cancer causing impurityThe list of blood pressure drugs recalled because they may contain a cancer-causing impurity has been expanded to include nearly five dozen products from 12 different pharmaceutical companies.

On July 13, the Food and Drug Administration (FDA) first announced a recall of certain valsartan tablets because they were found to contain a chemical known a N-nitrocodimethylamine (NDMA) in levels that exceeded those considered acceptable for public safety. The chemical, which is sometimes found in water supplies and food, is classified by the Environmental Protection Agency (EPA) as a probable human carcinogen – something that can increase the risk of cancer in humans.

In the weeks since the recall was initiated, the FDA has expanded the list of affected valsartan products. The agency also announced that the impurity may have been present in some of the drugs for as long as four years.

The impurity was first identified in valsartan products in Europe and the United Kingdom in early July.

Valsartan is in a class of drugs called angiotensin II receptor blockers (ARB). The drug is commonly used to treat high blood pressure and heart failure. Valsartan is made by numerous manufacturers. Not all valsartan-containing products are included in the recall.

The first round of valsartan products were linked to Chinese supplier Zhejiang Huahai Pharmaceuticals. The FDA later identified supplier Hetero Labs as another source of the impurity.

Valsartan-containing products affected by the recall were manufactured by the following pharmaceutical companies – Teva Pharmaceuticals labeled as Major Pharmaceuticals; Prinston Pharmaceuticals Inc., labeled as Solco Healthcare LLC; Teva Pharmaceuticals USA labeled as Actavis; AvKARE; Remedy Repack; A-S Medication Solutions LLC; Bryant Ranch Prepack Inc.; H.J. Harkins Company Inc., doiong business as Pharma Pac; Proficient Rx LP; Northwind Pharmaceuticals; Camber Pharmaceuticals Inc.; and NuCare Pharmaceuticals Inc.

Many manufacturers produce multiple dosage strengths and not all are affected by the recall. The FDA provided this list of affected valsartan products.

The FDA investigation is ongoing as the FDA continues to test samples of valsartan and finished products to confirm the extent and amount of NDMA. The agency has also contacted other manufacturers of valsartan to determine if their manufacturing processes are at risk for the formation of NDMA, and is working with them to ensure the chemical is not present in future valsartan products.

FDA Recall Update
FDA Recall Listing
Righting Injustice