China NMPA Drug Inspection - Shaanxi Xingshengde Pharmaceutical Co., Ltd. - Lactulose oral solution

The National Medical Products Administration (NMPA) of China announced in October 2019, through Announcement No. 75, that 83 batches of drugs from 68 companies failed to meet quality regulations. Notable companies implicated included Bicon Pharmaceutical Xinyi Group, Tianjin Jinyao Group Hubei Tianyao Pharmaceutical, Shaanxi Xingbang Pharmaceutical, and various traditional Chinese medicine (TCM) manufacturers. The violations spanned critical quality attributes. Issues for injectables like Dexamethasone Sodium Phosphate and Sodium Alginate Diester involved "related substances" and "visible foreign matter," indicating purity and contamination concerns. Oral solutions, such as Lactulose, exhibited "microbial limits" failures. Many products, including Piperacillin Sodium/Tazobactam Sodium for Injection, Synovitis Tablets, Tianma Zhuifeng Ointment, Psoralea corylifolia, and Saposhnikovia divaricata, failed "content determination" tests, suggesting incorrect active ingredient levels. Furthermore, TCM products like Niuhuang Jiedu Tablets contained "other plant tissues," while several fermented soybean batches showed "properties" (appearance) deviations. Operating under the "Drug Administration Law of the People's Republic of China" and relevant pharmacopoeial standards, the NMPA mandated immediate actions. Companies must cease sales, recall affected drugs, investigate the root causes of non-compliance, and implement corrective measures. Provincial drug regulatory authorities are required to investigate these illegal activities and publicly report their findings within three months, reinforcing the NMPA's commitment to drug quality and patient safety.