Core Viewpoint - The National Medical Products Administration (NMPA) announced that 28 batches of drugs produced by 17 companies do not meet regulatory standards, highlighting quality control issues in the pharmaceutical industry [1][2][3]. Summary by Categories Non-compliance Details - Five batches of fusidic acid cream produced by Aumei Pharmaceutical are non-compliant due to particle size [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 tosylate 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 Shenhou Pharmaceutical are non-compliant due to weight differences [1] Additional Non-compliance Findings - 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] Regulatory Actions - The NMPA has mandated that the involved companies take risk control measures such as halting 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] Public Awareness Initiatives - The NMPA has provided educational information regarding the significance of various non-compliance indicators, such as particle size, related substances, relative density, dissolution rate, physical properties, weight differences, content measurement, identification, pesticide residues, total reducing sugars, impurities, and moisture content [4][5]
国家药监局通告28批次药品不符合规定