The U.S. Food and Drug Administration (FDA) says that it has expanded its voluntary recall of several medications used to treat high blood pressure and heart failure.
The FDA said that traces of N-nitrosodimethylamine were found in valsartan, the active ingredient in the drug, and it is known to cause cancer.
Valsartan – Prinston – Pharmaceutical Inc.
Valsartan – AvKARE
Valsartan – A-S Medication Solutions LLC
Valsartan – Bryant Ranch Prepack, Inc.
Valsartan – HJ Harkins Company
Valsartan – Major Pharmaceuticals
Valsartan – Solco Healthcare
Valsartan – Northwind Pharmaceuticals
Valsartan – Teva Pharmaceuticals USA labeled as Actavis
Valsartan – Teva Pharmaceuticals labeled as Major Pharmaceuticals
Valsartan/Hydrochlorothiazide (HCTZ) – Proficient Rx LP
Valsartan/Hydrochlorothiazide (HCTZ) – Remedy Repack
Valsartan/Hydrochlorothiazide (HCTZ) – Solco Healthcare
“FDA is working with drug manufacturers to ensure future valsartan active pharmaceutical ingredients (APIs) are not at risk of NDMA formation. The agency reminds manufacturers to thoroughly evaluate their API manufacturing processes, and changes to those processes, to detect any unsafe impurities. If a manufacturer detects new or higher levels of impurity, they should take action to prevent changes to the product’s safety profile,” said the FDA.
Chinese-Made Drug
The first recall notices were issued on July 13 that 29 types of single and 51 types of combination valsartan medicines are being recalled. Later, the European Medicines Agency (EMA) announced a recall of the drug on July 5 when it was informed by China’s Zhejiang Huahai Pharmaceutical—a major global manufacturer of generic valsartan—that the drug had been contaminated.The recall highlights how defective medicines and pharmaceutical ingredients made by Chinese companies can be a health hazard in the United States and in other parts of the world.
“The public wants their medicine to be safe. This carcinogen hidden in valsartan raises the question whether other products that are made in China have been made contrary to the global standard we came to accept.”