China NMPA Drug Inspection - Yulin Bencaotang Chinese Herbal Medicine Pieces Co., Ltd. - Prepared Sichuan aconite

The National Medical Products Administration (NMPA) issued an announcement on August 20, 2020, detailing findings from drug testing where 25 batches of drugs from 20 pharmaceutical companies were found to be non-compliant. Key manufacturers included Henan Furen Huaiqingtang Pharmaceutical Co., Ltd., Chengdu Tongde Pharmaceutical Co., Ltd., Shanxi Qianhui Pharmaceutical Co., Ltd., and Henan Tianzhi Pharmaceutical Co., Ltd., among others. Main violations encompassed critical quality issues such as solution clarity and color, presence of visible foreign matter, elevated microbial counts (total mold, yeast, and aerobic bacteria), incorrect appearance, deviations in acid-insoluble ash content, fill weight uniformity, moisture levels, identification, and content determination. These products failed to meet standards outlined in the Pharmacopoeia of the People's Republic of China and various National Drug Standards. In response, the NMPA mandated immediate risk control measures, including suspending sales, recalling affected drugs, and requiring companies to investigate root causes and implement effective rectification. Provincial drug regulatory authorities were further instructed to investigate these breaches in accordance with the "Drug Administration Law of the People's Republic of China" and publicly disclose their findings.