China NMPA Drug Inspection - Sichuan Zhongxing Pharmaceutical Co., Ltd. - Atractylodes lancea

In an announcement dated December 3, 2020, the Sichuan Provincial Drug Administration revealed that 17 batches of pharmaceutical products from 17 different companies failed to meet national quality standards. Key companies identified include Wuhan Taifu Pharmaceutical Co., Ltd., Sichuan Zhuoyu Pharmaceutical Co., Ltd., Sichuan Limin Traditional Chinese Medicine Pieces Co., Ltd., and several others specialized in traditional Chinese medicine. The inspections, carried out by 12 regional testing institutions, uncovered significant quality violations. Major issues included failures in content uniformity for granules, excessive levels of magnesium and aluminum salts, and high moisture or ash content in medicinal pieces. Additionally, several products failed content determination tests—indicating active ingredients were not at required levels—and others failed microscopic identification, which relates to the authenticity and purity of the materials. These findings are governed by the Drug Administration Law of the People's Republic of China and the 2015 Chinese Pharmacopoeia. As a result, the regulatory authorities have mandated immediate risk control measures. The involved enterprises must suspend all sales and use of the non-compliant batches and initiate formal product recalls. They are also required to conduct internal investigations to identify the root causes of the quality failures and implement effective corrective rectifications. Local regulatory departments have been instructed to pursue administrative investigations into the production and sale of substandard drugs and to publicly disclose the results of these enforcement actions.