# China NMPA Drug Inspection - Zhengzhou Minzhong Pharmaceutical Co., Ltd. - Dexamethasone sodium phosphate injection

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/zhengzhou-minzhong-pharmaceutical-co-ltd/5afe1412-b020-43b5-bd10-6b4e961fe7ea/
Source feed: China

> China NMPA drug inspection for Zhengzhou Minzhong Pharmaceutical Co., Ltd. published September 26, 2019. Drug: Dexamethasone sodium phosphate injection. On September 26, 2019, the National Medical Products Administration (NMPA) announced findings from drug quality tests, i

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 68 of 2019 from the National Medical Products Administration regarding 7 batches of drugs that did not meet the requirements.
- Company Name: Zhengzhou Minzhong Pharmaceutical Co., Ltd.
- Publication Date: 2019-09-26
- Drug Name: Dexamethasone sodium phosphate injection
- Inspection Finding: It is evident that the foreign object does not comply with regulations.
- Action Taken: Sales and use have been suspended, products have been recalled, and investigations and rectifications have been carried out. The relevant provincial drug regulatory authorities will investigate the illegal activities and complete the investigation and handling within three months and make the results public.
- Summary: On September 26, 2019, the National Medical Products Administration (NMPA) announced findings from drug quality tests, identifying seven batches of non-compliant drugs from four pharmaceutical companies. Harbin Tianmu Pharmaceutical Co., Ltd. had one batch of Calcium Gluconate Oral Solution with an incorrect fill volume. Huazhong Pharmaceutical Co., Ltd. and Zhengzhou Zhuofeng Pharmaceutical Co., Ltd. each had batches of Dexamethasone Sodium Phosphate Injection containing visible foreign matter. Luoyang Tiansheng Pharmaceutical Co., Ltd. was cited for four batches of Lumbar Pain Tablets found to contain rosin acid, indicating potential raw material adulteration. These violations were identified against standards such as the Pharmacopoeia of the People's Republic of China and NMPA regulations. The NMPA mandated immediate risk control measures for the implicated companies, including suspending sales, recalling affected products, investigating root causes, and implementing corrective actions. Furthermore, provincial drug regulatory authorities were directed to conduct investigations into these illegal production and sales activities under the Drug Administration Law of the People's Republic of China. These investigations must conclude and their results be publicized within three months, emphasizing the strict regulatory oversight and commitment to drug safety in China.

Company: https://www.globalkeysolutions.net/companies/zhengzhou-minzhong-pharmaceutical-co-ltd/1e9946d9-331e-45f1-b9a0-592b25207fa3/