China NMPA Drug Inspection - Ningxiang County People"s Hospital - Potassium chloride oral solution

The Hunan Provincial Food and Drug Administration published its 2018 First Issue Drug Quality Bulletin, detailing results from drug quality inspections conducted across the province between November and December 2017. Out of 864 batches of drugs sampled from production, distribution, and user units, 22 batches were found to be substandard. The primary issues identified included failures related to microbial limits, fill weight discrepancies, incorrect moisture content, content uniformity, relative density, and active ingredient content. Some preparations also failed identification tests or did not meet specific provincial medical institution preparation standards. The non-compliant drugs originated from various medical institutions and one traditional Chinese medicine development company, with inspections based on the *Hunan Provincial Medical Institution Preparation Standards* (2016 Edition), *Chinese Pharmacopoeia* (2015 Edition), and *Ministry of Health Drug Standards*. In response, regulatory authorities have implemented control measures, including sealing and seizing the affected products. Municipal and prefectural food and drug administrations are mandated under Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China* to investigate the responsible entities. They are required to announce risk control measures within one week and publicly report resolution outcomes within three months. Cases involving suspected counterfeit drugs will be referred to public security departments for criminal investigation.