China NMPA Drug Inspection - Shaanxi Kexing Pharmaceutical Co., Ltd. - Prepared white aconite

The Shaanxi Provincial Drug Administration released its sixth Drug Quality Bulletin of 2020 on June 23, documenting a series of province-wide sampling inspections aimed at ensuring public medication safety. The report identifies six batches of traditional Chinese medicine products that failed to meet national quality standards. Primary companies named in the report include Shaanxi Kexing Pharmaceutical Co., Ltd. and Anguo City Qiao Traditional Chinese Medicine Pieces Limited Liability Company, although the latter has denied manufacturing some of the implicated batches found at healthcare facilities. The inspections revealed several critical quality issues across various products, including Mulberry Leaf and Licorice Tablets. Specifically, the batches failed testing for extractives, content determination, physical properties, and general inspection parameters. These failures indicate that the drugs either lacked the required concentration of active ingredients or possessed improper physical characteristics. All evaluations were conducted under the regulatory framework of the Chinese Pharmacopoeia 2015 Edition (Part I). In response to these findings, the Shaanxi provincial authorities have directed local municipal and county regulatory bodies to implement immediate control measures. These actions include securing non-compliant inventory at hospitals and pharmacies, such as the Suide County Traditional Chinese Medicine Hospital and Wugong Ren'ai Hospital. Furthermore, the administration is conducting ongoing investigations into the involved manufacturers and distributors to enforce drug safety laws and determine appropriate legal penalties.