China NMPA Drug Inspection - Shanxi Guorun Pharmaceutical Co., Ltd. - Acetylcysteine ​​injection

In September 2022, the National Medical Products Administration (NMPA) issued Announcement No. 43, revealing that 17 batches of pharmaceutical products failed to meet national quality standards. The findings resulted from testing conducted by multiple institutions, including the Hubei Provincial Institute for Drug Control and the China National Institutes for Food and Drug Control. Fourteen companies were implicated, including Shanxi Guorun Pharmaceutical Co., Ltd., Hubei Tongdetang Pharmaceutical Co., Ltd., and several traditional medicine suppliers such as Shanghai Wanshicheng Pharmaceutical Co., Ltd. Main violations identified during the inspections included excessive hydrogen sulfide in acetylcysteine injections, improper methanol levels in Huoxiang Zhengqi Water, and prohibited pesticide residues in chrysanthemum samples. Other issues included failures in product appearance and identification for traditional root medicines. Operating under the Drug Administration Law of the People's Republic of China, the NMPA has mandated immediate risk control measures. The involved enterprises must suspend the sale and use of the non-compliant products and initiate formal recalls. Additionally, companies are required to investigate the root causes of these quality failures and implement comprehensive rectifications. Provincial regulatory authorities have been directed to investigate potential illegal activities and publicly disclose the results of their findings to ensure industry compliance and public safety.