国家药监局今天通告28批次药品不符合规定

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 from the involved companies [1][3]. Summary by Categories Non-compliance Details - Five batches of fusidic acid cream produced by Aumei Pharmaceutical Factory failed due to particle size issues [1]. - Two batches of loratadine syrup from Wante Pharmaceutical (Hainan) Co., Ltd. did not meet standards due to related substances [1]. - One batch of sodium phosphate oral solution from Shanghai Haihong Industrial (Group) Co., Ltd. failed due to relative density [1]. - Two batches of tocilizumab capsules from Shaanxi Xiyue Pharmaceutical Co., Ltd. did not meet standards due to dissolution rate [1]. - One batch of acetylcysteine effervescent tablets from Zhejiang Jinhua Kang'enbei Biopharmaceutical Co., Ltd. failed due to physical properties [1]. - Two batches of Twenty-five Flavor Coral Pills from Tibet Shenhui Pharmaceutical Co., Ltd. did not meet standards due to weight differences [1]. Additional Non-compliance Cases - Two batches of Qili Powder from Hubei Minkan Pharmaceutical Co., Ltd. failed due to content determination [2]. - Four batches of Qingqi Huatan Pills from Hubei Ruihua Pharmaceutical Co., Ltd. did not meet standards due to dosage discrepancies [2]. - Two batches of red peony from Sichuan Jinke Pharmaceutical Co., Ltd. and Sichuan Yixiangkang Pharmaceutical Co., Ltd. failed due to physical properties [2]. - Three batches of red ginseng (red ginseng slices) from multiple companies failed due to identification issues and pesticide residue [2]. - One batch of Gentian from Jiangsu Heshengtang Pharmaceutical Co., Ltd. did not meet standards due to impurities [2]. - One batch of wild chrysanthemum from Jiangxi Xinjian Pharmaceutical Co., Ltd. failed due to content determination [2]. Regulatory Actions - The NMPA has mandated that the involved companies take risk control measures such as suspending sales and conducting recalls [3]. - Investigations into the causes of non-compliance are required, and the NMPA will pursue legal actions against any violations [3]. - The NMPA provided public education on the significance of various non-compliance indicators, including particle size, related substances, relative density, dissolution rate, physical properties, weight differences, content determination, identification, pesticide residues, total reducing sugars, impurities, and moisture content [3][4].