国家药监局关于28批次不符合规定药品的通告（2025年第47号）
Zhong Guo Zhi Liang Xin Wen Wang·2026-01-06 08:55

Summary of Key Points Core Viewpoint - A total of 28 batches of drugs produced by 24 companies were found to be non-compliant with regulations as per inspections conducted by various drug testing institutions in China [2][3][4]. Group 1: Non-compliant Drugs and Companies - Four batches of Coenzyme Q10 injection produced by Liaoning Zhonghai Kangsheng Biopharmaceutical Co., Ltd., Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd., and Kangpu Pharmaceutical Co., Ltd. were found non-compliant due to issues related to appearance, insoluble particles, visible foreign matter, and content measurement [2][3]. - Two batches of sodium bicarbonate injection produced by Chenxin Pharmaceutical Co., Ltd. and China Resources Sanjiu Li Min Pharmaceutical (Jinan) Co., Ltd. were non-compliant due to visible foreign matter and pH value [2][3]. - Two batches of Twenty-Five Flavor Coral Pills produced by Tibet Changdu Guangyu Limin Pharmaceutical Co., Ltd. tested positive for 808 scarlet [2][3]. - One batch of mulberry bark produced by Chengdu Tiansheng Traditional Chinese Medicine Co., Ltd. was non-compliant due to appearance issues [2][3]. - Seven batches of Pueraria lobata produced by Zhejiang Dade Hall National Medicine Co., Ltd., Hunan Taoyuan Traditional Chinese Medicine Co., Ltd., Sichuan Jinke Pharmaceutical Co., Ltd., Sichuan Shengshi Jinrong Pharmaceutical Co., Ltd., and Sichuan Yifang Traditional Chinese Medicine Co., Ltd. were found non-compliant due to appearance issues [2][3]. Group 2: Regulatory Actions - The drug supervision management departments have mandated the relevant companies to take risk control measures such as suspending sales, recalling products, and conducting investigations into the causes of non-compliance [3][4]. - The National Medical Products Administration has instructed provincial drug supervision departments to investigate suspected illegal activities by the companies involved and to publicly disclose the results of the investigations as per the Drug Administration Law of the People's Republic of China [3][4].