China NMPA Drug Inspection - Shaanxi Kangyu Pharmaceutical Co., Ltd. - Prepared Sichuan aconite

The Shaanxi Provincial Drug Administration published its 11th Drug Quality Bulletin of 2020 on November 25, 2020, following a series of province-wide sampling inspections. The report identifies three batches of non-compliant drugs produced by two manufacturers: Shaanxi Hanyi Shengcaotang Pharmaceutical Co., Ltd. and Shaanxi Kangyu Pharmaceutical Co., Ltd. The specific products involved include Radix Bupleuri, Lygodium japonicum, and Prepared Aconitum carmichaelii. According to the bulletin, these products failed to meet the quality standards established in the 2015 Edition of the Chinese Pharmacopoeia. The violations primarily concerned physical appearance, identification characteristics, and specific laboratory inspection criteria. Testing was conducted by the Xi'an Municipal Institute for Food and Drug Control. In response to these findings, provincial and municipal drug regulatory departments have implemented immediate control measures to secure the affected batches. Additionally, authorities have initiated formal investigations and legal proceedings against the involved entities to ensure compliance with national drug safety regulations and protect public health. The administration noted that these proactive disclosures are part of a broader effort to strengthen medication supervision throughout the region.