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

The Shandong Provincial Food and Drug Administration issued an announcement on December 20, 2017, reporting findings from quality sampling inspections. Six batches of drugs from six 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 main violations centered on the failure of these drug products to meet established quality standards, specifically regarding characteristic chromatograms and other critical inspection items. This indicates a deviation from their approved quality specifications.Under the provincial regulatory framework for drug quality supervision, authorities have taken immediate and stringent actions. These include sealing, seizing, suspending sales, and recalling the substandard drugs. Additionally, investigations and legal prosecutions have been initiated against the implicated manufacturers and sampled units. The municipal food and drug administrations are required to enhance oversight of these products and enterprises, ensuring they identify the root causes of the deficiencies, formulate and implement effective rectification measures, and eliminate potential risks to public health.