国家药监局关于28批次不符合规定药品的通告（2025年第30号）

Core Viewpoint - The National Medical Products Administration (NMPA) announced that 28 batches of drugs produced by 17 companies do not meet regulatory standards, prompting investigations and corrective actions [3][5]. Group 1: Non-compliant Drugs - Five batches of fusidic acid cream produced by Aomei Pharmaceutical Factory failed due to particle size issues [3]. - Two batches of loratadine syrup from Want Pharmaceutical (Hainan) Co., Ltd. did not meet standards related to impurities [3]. - One batch of sodium phosphate oral solution from Shanghai Haihong Industrial Group's Chao Hu Jinchen Pharmaceutical Co., Ltd. failed due to relative density [3]. - Two batches of tocilizumab capsules from Shaanxi Xiyue Pharmaceutical Co., Ltd. did not meet dissolution rate standards [3]. - One batch of acetylcysteine effervescent tablets from Zhejiang Jinhua Kang'enbei Biopharmaceutical Co., Ltd. failed due to physical characteristics [3]. - Two batches of Twenty-five Flavor Coral Pills from Tibet Shenhui Pharmaceutical Co., Ltd. did not meet weight difference standards [3]. - Two batches of Qili San from Hubei Minkan Pharmaceutical Co., Ltd. failed due to content determination [3]. Group 2: Regulatory Actions - The NMPA has mandated that the involved companies take risk control measures such as suspending sales and conducting recalls [5]. - The NMPA requires provincial drug supervision departments to investigate potential illegal activities by the companies involved and to publicly disclose the results of these investigations [5].