VALSARTAN UPDATE: FDA places Zhejiang Huahai Pharmaceuticals on import alert- Drug Information Update

FDA placed Zhejiang Huahai Pharmaceuticals on import alert on September 27, 2018, to protect U.S. patients while the active pharmaceutical ingredient (API) manufacturer fully determines how impurities were introduced into its API and remediates its quality systems. The import alert stops all API made by ZHP and finished drug products made using ZHP’s API from legally entering the United States. FDA’s action follows a recent inspection at ZHP’s facility. FDA reminds manufacturers that it is their responsibility to develop and use suitable methods to detect impurities, including when they make changes to their manufacturing processes. If a manufacturer detects new or higher levels of impurities, they should fully evaluate the impurities and take action to ensure the product is safe for patients. For more information, please visit: FDA updates on valsartan recalls.