# China NMPA Product Recall - Refined Coronary Tablets

Source: https://www.globalkeysolutions.net/records/china_product_recall/jilin-huinan-tianyu-pharmaceutical-co-ltd/c6eb63b1-691e-40d1-aaaf-127e12dc9bff/
Source feed: China

> China NMPA product recall for Refined Coronary Tablets by Jilin Huinan Tianyu Pharmaceutical Co., Ltd. published December 28, 2015. Recall level: . The National Medical Products Administration (NMPA) announced on December 28, 2015, significant prod

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Announcement No. 109 of 2015 from the State Food and Drug Administration regarding the illegal production of refined coronary heart disease tablets by companies including Jilin Huinan Sanhe Pharmaceutical Co., Ltd.
- Company Name: Jilin Huinan Tianyu Pharmaceutical Co., Ltd.
- Publication Date: 2015-12-28
- Product Name: Refined Coronary Tablets
- Recall Reason: The detection of plant tissue in the retained samples indicates that the aforementioned companies used powdered medicinal herbs such as Salvia miltiorrhiza, Ligusticum chuanxiong, Paeonia lactiflora, and Carthamus tinctorius as raw materials, reducing key production steps such as herb extraction, and violating the registered application process for drug production. Using powdered medicinal herbs directly as raw materials and reducing extraction steps can both affect drug quality and efficacy.
- Discovering Company: State Food and Drug Administration
- Manufacturing Company: Jilin Huinan Tianyu Pharmaceutical Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/jilin-huinan-tianyu-pharmaceutical-co-ltd/e406ba27-1dcd-4955-9f5c-ff8c66c15507/