China NMPA Drug Inspection - Shaanxi Pharmaceutical Holding Group Shanhaidan Pharmaceutical Co., Ltd. - Benzylpenicillin oral solution

On November 26, 2024, China’s National Medical Products Administration (NMPA) issued Announcement No. 51, reporting that 28 batches of drugs from 23 companies failed to meet national quality standards. Testing conducted by various provincial institutes identified significant safety and quality issues across multiple product categories. Key manufacturers cited include Shijiazhuang Green Pharmaceutical, Jiangsu Yuanheng Pharmaceutical, and Guangdong Hengjian Pharmaceutical for visible foreign matter in eye drops. Other violations included chemical stability failures in enemas from Jingzhou Jinfeng Pharmaceutical, purity issues in oral solutions from Shaanxi Guanai Pharmaceutical, and microbial contamination in tablets from Jilin Junhong Pharmaceutical. Additionally, numerous Traditional Chinese Medicine producers, such as Hangzhou Kanglun and Bozhou Shenghai, failed requirements regarding appearance and active ingredient levels. These inspections were governed by the Drug Administration Law and the 2020 Chinese Pharmacopoeia. In response, the NMPA has ordered all affected parties to immediately suspend sales, recall non-compliant products, and investigate the root causes of these failures. Provincial regulatory bodies are further instructed to initiate formal investigations into suspected illegal activities and publicly disclose the results of their enforcement actions.