国家药监局发布通告28批次药品不符合规定

Summary of Key Points Core Viewpoint - The National Medical Products Administration (NMPA) has 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]. Group 1: Non-compliance Details - Five batches of fusidic acid cream produced by Aumei Pharmaceutical are non-compliant due to particle size issues [1] - Two batches of loratadine syrup from Wante Pharmaceutical (Hainan) are non-compliant due to related substances [1] - One batch of sodium phosphate oral solution from Shanghai Haihong Industrial Group is non-compliant due to relative density [1] - Two batches of tocilizumab capsules from Shaanxi Xiyue Pharmaceutical are non-compliant due to dissolution rate [1] - One batch of acetylcysteine effervescent tablets from Zhejiang Jinhua Kang'enbei Biopharmaceutical is non-compliant due to physical properties [1] - Two batches of Twenty-Five Flavor Coral Pills from Tibet Shenhui Pharmaceutical are non-compliant due to weight differences [1] Group 2: Additional Non-compliance Cases - Two batches of Qili Powder from Hubei Minkan Pharmaceutical are non-compliant due to content measurement [2] - Four batches of Qingqi Huatan Pills from Hubei Ruihua Pharmaceutical are non-compliant due to dosage discrepancies [2] - Two batches of red peony from Sichuan Jinke Pharmaceutical and Sichuan Yixiangkang Pharmaceutical are non-compliant due to physical properties [2] - Three batches of red ginseng (red ginseng slices) from multiple companies are non-compliant due to identification issues and pesticide residue [2] - One batch of Gentian from Jiangsu Heshengtang Pharmaceutical is non-compliant due to impurities [2] - One batch of wild chrysanthemum from Jiangxi Xinjian Pharmaceutical is non-compliant due to content measurement [2] Group 3: 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, along with corrective actions [3] - Provincial drug supervision departments are instructed to investigate potential illegal activities by the companies involved [3]