China NMPA Drug Inspection - Chenzhou First People"s Hospital - Potassium chloride oral solution

On February 1, 2021, the Hunan Provincial Drug Administration released an announcement regarding 30 batches of pharmaceutical products that failed quality standards during provincial spot checks. The inspection encompassed various stages of the supply chain, including production, wholesale, and retail distribution. Affected companies include manufacturers such as Guangxi Jinye Pharmaceutical Co., Ltd., Hunan Jinshitang Traditional Chinese Medicine Pieces Co., Ltd., and several healthcare facilities, including Chenzhou First People’s Hospital and Anhua County Traditional Chinese Medicine Hospital. The primary violations identified involve traditional Chinese medicine (TCM) materials and preparations failing to meet criteria for sulfur dioxide residues, moisture levels, and microbial limits. Additional issues noted include improper weight variation in tablets, the presence of excessive impurities, and failures in microscopic and chemical identification. These quality assessments were based on the regulatory framework of the Chinese Pharmacopoeia (2015 Edition) and the Hunan Provincial Medical Institution Preparation Standards (2016 Edition). The Hunan Provincial Drug Administration has directed relevant local departments to take legal action and enforce risk control measures. The implicated companies are required to immediately suspend sales, recall non-compliant products, and perform a detailed root-cause analysis. Furthermore, these entities must implement comprehensive rectification plans to ensure all future products adhere to safety and quality standards.