China NMPA Drug Inspection - Hebei Quantai Pharmaceutical Co., Ltd. - Atractylodes lancea

In December 2021, the National Medical Products Administration (NMPA) issued Announcement No. 96 regarding two batches of traditional Chinese medicine that failed to meet national quality standards. The affected products were labeled as being manufactured by Hebei Quantai Pharmaceutical Co., Ltd. and included one batch of Atractylodes lancea and one batch of Aucklandia lappa. Laboratory testing conducted by provincial institutes in Hubei and Qinghai identified significant quality failures: the Atractylodes lancea failed content determination requirements for active ingredients, while the Aucklandia lappa exceeded permitted levels for total ash content, which serves as a measure of product purity. A key finding of the investigation was that the labeled manufacturer, Hebei Quantai Pharmaceutical Co., Ltd., did not actually produce these batches, suggesting the products are counterfeit. Operating under the Drug Administration Law of the People's Republic of China, the NMPA has mandated immediate risk control measures, including the suspension of sales and use, and a comprehensive recall of the drugs. Regulatory authorities are now required to investigate the illegal production and sale of these substandard products, trace their source, and publicly disclose the findings of their investigations to ensure public safety.