China NMPA Drug Inspection - Jilin Yizheng Pharmaceutical Group Co., Ltd. - Roxithromycin tablets

An announcement published on September 14, 2017, by the State Administration for Market Regulation (NMPA), detailed findings of substandard drugs from two manufacturers. Based on tests by two drug testing institutions, including the Dalian Municipal Institute for Drug Control, six batches of products were identified as non-compliant. Sanmenxia Guangyu Biopharmaceutical Co., Ltd. was cited for five batches of its Qinghouyan Mixture (batch numbers 161001, 161003, 161004, 161103, and 161201) failing to meet microbial limits. Additionally, Jilin Jingxin Pharmaceutical Group Co., Ltd.'s Roxithromycin Tablets (batch number 20160802) exhibited an unsatisfactory dissolution rate. In response to these issues, provincial food and drug administrations took immediate control measures, including sealing and seizing the affected drugs. The involved companies were mandated to suspend sales and use of the products, initiate recalls, and implement necessary corrective actions. Furthermore, provincial regulators were instructed to investigate these violations in accordance with Articles 73, 74, and 75 of the "Drug Administration Law of the People's Republic of China." They are required to publicly disclose the investigation outcomes within three months and report their findings to the State Food and Drug Administration, ensuring compliance and safeguarding public health.