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

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jilin-shuangxing-pharmaceutical-co-ltd/5bbb8a40-8d11-4699-8592-714a72c30425/
Source feed: China

> China NMPA drug inspection for Jilin Shuangxing Pharmaceutical Co., Ltd. published December 07, 2016. Drug: Traumatic Injury and Blood Circulation Powder. On December 7, 2016, the China Food and Drug Administration (CFDA) announced findings from national drug sampling inspec

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: The State Administration of Drug Administration issued Announcement No. 159 of 2016 regarding the detection of rosin acid or 808 scarlet in 6 batches of drugs from 5 companies including Jilin Yongli Pharmaceutical Co., Ltd.
- Company Name: Jilin Shuangxing Pharmaceutical Co., Ltd.
- Publication Date: 2016-12-07
- Drug Name: Traumatic Injury and Blood Circulation Powder
- Inspection Finding: Rosin acid was detected, which is an illegally added substance, indicating serious deficiencies in the company's production quality management.
- Action Taken: Products have been seized and impounded, sales and use have been suspended, and a voluntary recall has been required; production of related products has been ordered to be suspended, the cause of drug quality problems must be thoroughly investigated, and production may not resume until the cause is identified and rectified; the company has been placed under investigation in accordance with the "Drug Administration Law of the People's Republic of China" and other relevant regulations, and will be dealt with according to law; those suspected of committing crimes will be transferred to the public security organs for criminal prosecution.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/jilin-shuangxing-pharmaceutical-co-ltd/15164930-890b-44b4-8751-3b29d4acdfb4/