China NMPA Drug Inspection - Shanxi Fenhe Pharmaceutical Co., Ltd. - Piracetam tablets

This announcement from the State Administration for Market Regulation, published on December 1, 2017, detailed findings from 11 drug testing institutions. The regulatory review identified 39 batches of substandard drugs produced by 19 companies, including Jilin Lisheng Pharmaceutical Co., Ltd., Gansu Furen Pharmaceutical Technology Co., Ltd., and Shanxi Yunpeng Pharmaceutical Co., Ltd.

Key violations encompassed a range of quality deficiencies. Products like Anwei tablets, Piracetam tablets, and various granule and capsule formulations failed quality tests due to issues such as incorrect content determination, poor friability, inconsistent fill weight, inadequate dissolution rates, and microbial contamination. Notably, Hydroxyethyl starch 130/0.4 sodium chloride injection from Shandong Hualu Pharmaceutical Co., Ltd. was found to be contaminated with harmful substances, while other products exhibited problems with potency and appearance.

Operating under the Drug Administration Law of the People's Republic of China (specifically Articles 73, 74, and 75), the regulatory body mandated immediate actions. Provincial food and drug administrations were instructed to implement control measures including product sealing, seizure, suspension of sales and use, and recalls. Furthermore, companies are required to rectify the identified issues. Authorities must investigate the illegal production and sale activities, publicly disclose handling results within three months, and report findings to the State Food and Drug Administration.