# China NMPA Drug Inspection - Lu"an Huayuan Pharmaceutical Co., Ltd. - Tinidazole sodium chloride injection

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/luan-huayuan-pharmaceutical-co-ltd/aa3e23ca-6be0-42f6-a43c-bb4f62afc46e/
Source feed: China

> China NMPA drug inspection for Lu"an Huayuan Pharmaceutical Co., Ltd. published December 01, 2017. Drug: Tinidazole sodium chloride injection. This announcement from the State Administration for Market Regulation, published on December 1, 2017, detailed findings 

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: State Administration for Market Regulation Announcement No. 193 of 2017 Regarding 39 Batches of Substandard Drugs
- Company Name: Lu"an Huayuan Pharmaceutical Co., Ltd.
- Publication Date: 2017-12-01
- Drug Name: Tinidazole sodium chloride injection
- Inspection Finding: The drugs were found to be substandard, with substandard items including content determination, friability, fill weight variation, dissolution rate, microbial limits, visible foreign matter, potency determination, and appearance.
- Action Taken: The relevant provincial food and drug administrations have taken control measures such as sealing and seizing, requiring enterprises to suspend sales and use, recall products and make rectifications; and have initiated investigations in accordance with the "Drug Administration Law of the People's Republic of China" and made the results public.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/luan-huayuan-pharmaceutical-co-ltd/2d80851c-3260-47f8-ba16-6c8d6b21eb7d/