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

On October 31, 2024, the National Medical Products Administration (NMPA) issued Announcement No. 47, identifying 19 batches of pharmaceutical products from 17 companies that failed to meet quality standards. Notable manufacturers cited include Shanxi Guorun Pharmaceutical Co., Ltd., Henan Quanyu Pharmaceutical Co., Ltd., Tianfang Pharmaceutical Co., Ltd., and several traditional Chinese medicine providers such as Anhui Dechang Pharmaceutical and Sichuan Xinhehua. The violations, detected through testing by various provincial institutes, encompass a range of quality failures. Major issues include chemical deviations in injections, improper pH values, microbial contamination in pills, and excessive moisture content. Several batches of herbal medicines failed based on impurities or insufficient active ingredient concentrations. Physical discrepancies, such as incorrect fill volumes, weight variations, and improper particle size, were also documented. Regulated under the Drug Administration Law of the People's Republic of China, the NMPA has ordered immediate risk mitigation. Required actions for the involved companies include the suspension of sales and use, mandatory product recalls, and thorough investigations into the root causes of these failures. The NMPA has further instructed provincial authorities to pursue legal investigations into suspected illegal activities and publicly disclose all findings to ensure transparency and consumer safety.