China NMPA Product Recall - Refined Coronary Tablets

The National Medical Products Administration (NMPA) announced on December 28, 2015, significant production violations uncovered during recent unannounced inspections of refined coronary heart disease tablet manufacturers in Jilin and Shaanxi provinces. Four companies—Jilin Huinan Sanhe Pharmaceutical Co., Ltd., Jilin Huinan Tianyu Pharmaceutical Co., Ltd., Jilin Jichun Pharmaceutical Co., Ltd., and Xi'an Aslan Pharmaceutical Co., Ltd.—were found to have plant tissue in their product samples. This indicated they bypassed critical manufacturing steps, such as herb extraction, by directly using powdered medicinal herbs like Danshen and Chuanxiong, which violated their registered production processes and could compromise drug quality and efficacy.

These actions contravened the "Drug Administration Law of the People's Republic of China." The NMPA initiated an investigation into Xi'an Aslan Pharmaceutical Co., Ltd. and revoked its Good Manufacturing Practice (GMP) certificate, while the Jilin Provincial Food and Drug Administration is also investigating. All entities involved in selling or using these products were directed to immediately cease sales and usage, and provincial regulatory departments were tasked with supervising recalls. Additionally, all manufacturers of refined coronary heart disease tablets were ordered to conduct immediate self-inspections, cease any illegal production, recall non-compliant products, and report findings by January 20, 2016. The NMPA pledged continued surveillance and severe penalties for future violations.