China NMPA Drug Inspection - Jilin Shuangxing Pharmaceutical Co., Ltd. - Traumatic Injury and Blood Circulation Powder

On December 7, 2016, the China Food and Drug Administration (CFDA) announced findings from national drug sampling inspections, revealing serious quality control deficiencies at five pharmaceutical companies. Jilin Yongli Pharmaceutical Co., Ltd., Jilin Dongfeng Pharmaceutical Co., Ltd., and Jilin Shuangshi Pharmaceutical Co., Ltd. were found to have abietic acid (rosin acid) in multiple batches of their "Dieda Huoxue San" (Trauma and Blood Circulation Powder). Additionally, Jinhe Tibetan Medicine Co., Ltd. and Tibet Jinzhu Yalong Tibetan Medicine Co., Ltd. had 808 scarlet, a dye, detected in batches of their "Ershiwuwei Shanhu Wan" (Twenty-Five Flavor Coral Pills). These substances are considered illegally added, indicating a failure in production quality management. Local Food and Drug Administrations in Jilin, Qinghai, and Tibet initiated immediate product control measures, including sealing products, suspending sales, and mandating recalls. Under the "Drug Administration Law of the People's Republic of China," the CFDA required these companies to suspend production of affected products, thoroughly investigate and rectify the root causes, and face legal penalties. Further investigation into the origin of adulterated raw materials and potential criminal activity was also mandated, with requirements for public disclosure of findings.