China NMPA Drug Inspection - Hainan Guoruitang Traditional Chinese Medicine Pharmaceutical Co., Ltd. - earth dragon

The Henan Provincial Food and Drug Administration announced on March 29, 2018, findings from drug inspections revealing five batches of substandard medicines. Two companies, Henan Zhongxuan Traditional Chinese Medicine Pharmaceutical Co., Ltd. and Jilin Xinhui Pharmaceutical Co., Ltd., were associated with the problematic products, identified through samples from Zhengzhou First People's Hospital, Zhengzhou Sixth People's Hospital, and Fanxian Chengxin Pharmaceutical Co., Ltd. The primary violations concerned quality control and product authenticity. For Henan Zhongxuan, three batches of Puhuang, Baishao, and Dilong (batch number 170320) and one batch of Dilong (batch number 170518) were found non-compliant. Issues included impurities, excessive sulfur dioxide residue, content discrepancies, and appearance defects. These specific products are suspected to be counterfeit. Separately, Niuhuang Jiedu Tablets (batch number 52150802) from Jilin Xinhui Pharmaceutical Co., Ltd. failed inspection due to appearance issues. These findings were based on testing against established regulatory standards, including the Chinese Pharmacopoeia (2015 and 2010 editions) and Henan Provincial standards for traditional Chinese medicine processing. In response, the Henan Provincial Food and Drug Administration mandated immediate risk control measures, such as sealing, seizing, and suspending sales of the affected drugs. Furthermore, investigations and penalties are to be pursued against the entities involved in sourcing these substandard items, particularly focusing on the suspected counterfeit products.