China NMPA Drug Inspection - Jiangxi Pinxin Pharmaceutical Co., Ltd. - Motherwort granules

On December 28, 2021, the Shanghai Municipal Drug Administration published Announcement No. 37, detailing the results of the fourth batch of drug quality sampling inspections for 2021. The inspections identified quality failures across several pharmaceutical manufacturers, including Anhui Jishun Traditional Chinese Medicine Slices Co., Ltd., Shanghai Zhengda General Pharmaceutical Co., Ltd., Yunnan Jinke Pharmaceutical Co., Ltd., and Jiangxi Pinxin Pharmaceutical Co., Ltd. The main violations involved ten batches of products and included discrepancies in physical appearance, improper processing of herbal medicines, excessive moisture levels, and failures in content determination. Additionally, significant issues regarding microbial limits were discovered in creams and granules, while weight and content variation failures were found in tablet and granule formulations. These inspections were conducted under the regulatory framework of the Chinese Pharmacopoeia (2015 and 2020 Editions), focusing on the safety, efficacy, and purity of marketed drugs. In response to these findings, the Shanghai Municipal Drug Administration has mandated immediate actions, including the suspension of sales and use, as well as the recall of all non-compliant products. Regulatory departments are currently conducting legal investigations into the involved enterprises to ensure public safety and maintain market order.