China NMPA Drug Inspection - Hainan Star Pharmaceutical Co., Ltd. - Injectable Yanhuning

On July 2, 2020, the National Medical Products Administration (NMPA) issued Announcement No. 45, identifying 10 batches of drugs that failed to meet quality standards. The manufacturers involved include Chengdu Jinhua Pharmaceutical, Sichuan Chengdu Tongdaotang Pharmaceutical, Hainan Sida Pharmaceutical, Hainan Xinshitong Pharmaceutical, Jiangxi Jingtong Meilian Pharmaceutical, Jilin Yuren Pharmaceutical, Liaoning Haizhou Pharmaceutical, Anhui Jishantang Traditional Chinese Medicine Technology, Sichuan Pufengtang Pharmaceutical, and Pingliang Yongcheng Pharmaceutical. Testing conducted by various provincial institutes revealed several critical violations. Issues ranged from weight variation and incorrect active ingredient concentrations to excessive moisture, high microbial counts, and the presence of organic or inorganic impurities. Some traditional Chinese medicines also failed due to substandard physical characteristics, suggesting issues with processing or storage. In accordance with the 'Drug Administration Law of the People's Republic of China,' the NMPA has ordered immediate risk control measures. All relevant entities must suspend the sale and use of the non-compliant batches and initiate formal product recalls. Manufacturers are required to investigate the root causes of these failures and implement corrective actions. Additionally, provincial authorities have been directed to investigate the production of these substandard drugs and publicly report their findings.