China NMPA Drug Inspection - Shaanxi Haitian Pharmaceutical Co., Ltd. - Xuefu Zhuyu Tablets

On September 25, 2023, China’s National Medical Products Administration (NMPA) released Announcement No. 48 of 2023, detailing quality failures in 22 batches of pharmaceutical products from 14 companies. Major manufacturers identified in the report include Shaanxi Haitian Pharmaceutical Co., Ltd., Henan Hongri Kangrentang Pharmaceutical Co., Ltd., and Heilongjiang Wangda Traditional Chinese Medicine Pieces Technology Co., Ltd., along with several other traditional medicine processors. The inspection findings highlighted significant deviations from national quality standards. Key issues included failures in drug identification tests, excessive moisture content, and improper concentrations of active ingredients. Specifically, several batches of tablets and granules failed chromatography and fingerprinting tests, which are essential for verifying chemical characteristics. Other products, such as stir-fried jujube seeds and root barks, were flagged for high moisture and total ash content, suggesting poor storage conditions or purity issues. These violations fall under the 'Drug Administration Law of the People's Republic of China' and the 2020 edition of the National Pharmacopoeia. Consequently, the NMPA has ordered the immediate suspension of sales and usage of the affected drugs. The involved companies must initiate product recalls, investigate the root causes of these failures, and implement corrective actions. Provincial authorities have been tasked with launching formal legal investigations into these companies to determine if further disciplinary measures are required.