China NMPA Drug Inspection - Chongqing Kangle Pharmaceutical Co., Ltd - Epimedium (Chinese herbal medicine slices)

The Sichuan Provincial Drug Administration released an announcement on November 8, 2019, detailing findings from its 2019 provincial drug sampling inspection program. Inspections, conducted across drug production, distribution, and usage units, identified 12 batches of non-compliant drugs. Several pharmaceutical companies were implicated, including Guangxi Qianzhen Pharmaceutical Co., Ltd., Sichuan Juyuan Pharmaceutical Group Co., Ltd., and Xichang Jingkang High-tech Technology Industry Development Co., Ltd., among others. Main violations included quality issues such as unqualified tablet core weight, excessive mold and yeast, improper content of active ingredients (e.g., Epimedium), unsatisfactory physical properties, impurities, and sulfur dioxide residue, with reference to the 2015 edition of the Chinese Pharmacopoeia. In response, the regulatory body mandated that the involved enterprises immediately suspend sales and use of the affected products, initiate recalls, investigate the root causes of the non-compliance, and implement comprehensive corrective actions to ensure rectification.