China NMPA Drug Inspection - Shanxi Lifeng Huarui Pharmaceutical Co., Ltd. - Hydrochlorothiazide tablets

This document from the Shanxi Provincial Drug Administration, announced on December 8, 2020, details significant quality control failures in several drug products. Multiple pharmaceutical and traditional Chinese medicine companies were cited for non-compliance following product sampling. Shanxi Lifeng Huarui Pharmaceutical Co., Ltd. produced a batch of hydrochlorothiazide tablets that failed the dissolution rate test, which could impact drug absorption. Traditional Chinese medicine manufacturers, including Bozhou Huayun Traditional Chinese Medicine Pieces Co., Ltd., Anhui Wugeng Traditional Chinese Medicine Pieces Co., Ltd. (for two distinct products), and Anhui Runbang Traditional Chinese Medicine Pieces Co., Ltd., were found to have batches of herbal remedies (Akebia stem, Lysimachia christinae, Acanthopanax bark, and Amomum villosum) that failed appearance tests, indicating potential issues with raw materials or processing. Additionally, Jiuquan Peifeng Traditional Chinese Medicine Ecological Planting and Processing Co., Ltd.'s Scrophularia root failed total ash and content determination tests. Operating under the regulatory framework of the National Medical Products Administration (NMPA), the Shanxi Provincial Drug Administration investigated these issues. As required actions, the implicated enterprises and units implemented risk control measures, including suspending sales and use, and initiating product recalls to ensure public safety and adherence to quality standards.