# China NMPA Drug Inspection - Jiangsu Dahongying Hengshun Pharmaceutical Co., Ltd. - Racemic scopolamine hydrochloride injection

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jiangsu-dahongying-hengshun-pharmaceutical-co-ltd/39daa39f-fe06-4f09-94ba-d4afe0cb6801/
Source feed: China

> China NMPA drug inspection for Jiangsu Dahongying Hengshun Pharmaceutical Co., Ltd. published November 18, 2019. Drug: Racemic scopolamine hydrochloride injection. On December 20, 2017, the Shandong Provincial Food and Drug Administration, operating within the National Medical Produc

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from Shandong Provincial Food and Drug Administration Regarding 6 Batches of Substandard Drugs in Quality Spot Checks (Issue No. 10, 2017)
- Company Name: Jiangsu Dahongying Hengshun Pharmaceutical Co., Ltd.
- Publication Date: 2019-11-18
- Drug Name: Racemic scopolamine hydrochloride injection
- Inspection Finding: The quality of the medicine does not meet the standard requirements; the unqualified items are the characteristic chromatogram and the inspection items.
- Action Taken: Control measures such as sealing, seizure, suspension of sales, and product recall were taken, and cases were filed against the relevant manufacturers and sampled units in accordance with the law. The relevant municipal food and drug administrations should strengthen supervision, urge enterprises to investigate the causes of the problems, formulate and implement rectification measures, and effectively eliminate potential risks.
- Summary: On December 20, 2017, the Shandong Provincial Food and Drug Administration, operating within the National Medical Products Administration (NMPA) framework, announced significant quality control failures involving multiple pharmaceutical companies. During recent sampling inspections, six batches of drugs from various manufacturers were found to be substandard. The implicated companies include Shijiazhuang Northern Pharmaceutical Co., Ltd., Furen Pharmaceutical Group Co., Ltd., Jiangsu Dahongying Hengshun Pharmaceutical Co., Ltd., Haikou Qili Pharmaceutical Co., Ltd., Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. Baiyunshan Hejigong Pharmaceutical Factory, and Suzhou Yushi Pharmaceutical Co., Ltd. The primary violations involved critical quality attributes, specifically "characteristic chromatograms and inspection items," which indicate the drugs did not meet required quality standards. In response, municipal food and drug administrations have implemented control measures, including sealing, seizing, suspending sales, and recalling the affected products. Investigations and prosecutions have been initiated against the responsible manufacturers and sampled units. Moving forward, authorities mandate enhanced supervision of these products and enterprises, requiring them to investigate root causes, formulate and execute rectification measures, and effectively eliminate potential risks to public health and safety.

Company: https://www.globalkeysolutions.net/companies/jiangsu-dahongying-hengshun-pharmaceutical-co-ltd/0fe6b8da-f5ce-4e51-a1ee-03f97db25457/