# China NMPA Drug Inspection - Henan Tianzhi Pharmaceutical Co., Ltd. - Ozagrel sodium injection

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/henan-tianzhi-pharmaceutical-co-ltd/e2729620-1c17-4e38-acb4-24f7219f253d
Source feed: China

> China NMPA drug inspection for Henan Tianzhi Pharmaceutical Co., Ltd. published August 20, 2020. Drug: Ozagrel sodium injection. On August 20, 2020, China’s National Medical Products Administration (NMPA) issued Announcement No. 55, identifying 25 b

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 55 of 2020 from the National Medical Products Administration regarding 25 batches of drugs that did not meet the requirements.
- Company Name: Henan Tianzhi Pharmaceutical Co., Ltd.
- Publication Date: 2020-08-20
- Drug Name: Ozagrel sodium injection
- Inspection Finding: Visible foreign objects
- Action Taken: Risk control measures such as suspending sales and use and recalling products will be implemented. Investigations will be conducted into the reasons for non-compliance and rectification will be carried out, and cases will be filed for investigation.
- Summary: On August 20, 2020, China’s National Medical Products Administration (NMPA) issued Announcement No. 55, identifying 25 batches of drugs from 20 pharmaceutical companies that failed to meet national quality standards. Key companies named in the report include Henan Furen Huaiqingtang Pharmaceutical Co., Ltd., Chengdu Tongde Pharmaceutical Co., Ltd., and Shandong Luoxin Pharmaceutical Group Co., Ltd. The inspections, conducted by various regional drug institutes, identified several critical quality violations. Major issues included microbial contamination (excessive bacteria, mold, and yeast), the presence of visible foreign matter in injections, and failures in clarity, color, and moisture content. Additionally, several traditional Chinese medicine products failed identity tests and content uniformity standards, suggesting manufacturing inconsistencies. These findings were assessed under the Drug Administration Law of the People's Republic of China and the 2015 Edition of the Chinese Pharmacopoeia. As a result, the NMPA has ordered all involved enterprises to immediately suspend the sale and use of the affected products and initiate formal recalls. Companies are required to investigate the root causes of these failures and implement effective rectification measures. Furthermore, provincial authorities have been directed to organize legal investigations into the production of these substandard drugs and publicly disclose the results of their enforcement actions.

Company: https://www.globalkeysolutions.net/companies/henan-tianzhi-pharmaceutical-co-ltd/4e8c9ea4-2042-4ef6-8a72-2f941da3d128