China NMPA Drug Inspection - Hubei Xunda Pharmaceutical Co., Ltd. - Sodium chloride injection

On January 26, 2018, the Henan Provincial Food and Drug Administration announced findings from inspections conducted by various provincial and city-level drug inspection institutes, identifying four batches of substandard drugs. This action falls under the regulatory oversight of the Henan Provincial Food and Drug Administration, operating within China's National Medical Products Administration (NMPA) framework. The identified issues involved multiple entities.

Henan Qingshan Pharmaceutical Co., Ltd. produced Dictamnus dasycarpus root bark that was non-compliant due to unqualified levels of magnesium and aluminum salts. Agarwood sourced from Zhengzhou First People's Hospital was found to be deficient in rosin acid. Chuanbei Pipa Syrup, labeled as produced by Guilin Gexianweng Pharmaceutical Co., Ltd., failed content specifications. Additionally, Sodium Chloride Injection from Hubei Xinghua Pharmaceutical Co., Ltd. contained visible foreign matter.

As a result, the Henan Provincial Food and Drug Administration has directed relevant regulatory bodies to implement immediate risk control measures, including the sealing, seizure, and suspension of sales for the affected drugs. Further investigations will be conducted, and legal penalties will be applied to the responsible suppliers to ensure regulatory compliance and public safety.