Why was Valsartan Recalled?
In July of 2018, FDA began the voluntary valsartan recall when it was found the recalled drugs were contaminated with N-nitrosodimethylamine (NDMA). According to the FDA, “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.”
NDMA is an organic chemical used to make liquid rocket fuel, softeners, and lubricants, among other products. The FDA said, “the presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.”
Symptoms of exposure to high levels of NDMA may include headaches, fever, nausea, vomiting, and reduced function and damage to the kidneys, liver, and lungs as well as a risk of certain types of cancer.
The recalled Valsartan was manufactured in China by Zhejiang Huahai Pharmaceutical Co. Ltd. To date, the FDA has recalled valsartan products from Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries, as well as valsartan/hydrochlorothiazide from Solco and Teva.
In addition to the FDA recall, several other countries issued recalls for some 2,300 valsartan batches sent to Canada, Germany, Finland, Norway, Sweden, Hungary, Spain, the Netherlands, Ireland, Austria, Italy, Bulgaria, Portugal, France, Belgium, Croatia, Poland, Lithuania, Greece, Bosnia and Herzegovina, Bahrain and Malta.