FDA bans import of drugs from Chinese firm

In the patient care continuum, we also need to be cautious of the drugs that are prescribed to patients. The FDA blocked all imports of drugs made with ingredients made by a Chinese plant at the centre of a massive recall of heart and blood pressure medications. Zhejiang Huahai Pharmaceuticals will be on “import alert” until it “fully determines how impurities were introduced into its API,” or active pharmaceutical ingredient, and fixes its quality system.

This import alert puts a ban on all API made by ZHP and finished drug products that are made by using ZHP’s API from legally entering the United States. This action was taken after the FDA recalled blood pressure and heart failure medicines, because of the discovery of at least two potentially cancer-causing impurities.

Three lots of Torrent Pharmaceuticals’ valsartan drugs contained NDEA, known to cause cancer in animals and is believed to be a human carcinogen. Those drugs are a part of August’s recall of valsartan products for possible contamination with NDMA, another impurity that is suspected to cause cancer.

FDA says, Zhejiang Huahai Pharmaceuticals found the NDEA in various batches of its valsartan ingredients. More than 20 European countries, Canada and the United States have recalled valsartan medications.