China NMPA Drug Inspection - Sichuan Pharmaceutical Co., Ltd. - Calcium gluconate oral solution

An announcement released on September 11, 2017, by the Henan Provincial Food and Drug Administration, detailed the discovery of three batches of substandard drugs following tests conducted by the Luoyang Municipal Food and Drug Inspection Institute. The implicated companies and products include Hainan Haishen Tongzhou Pharmaceutical Co., Ltd. for Spironolactone tablets (batch 1610041), Anhui Xinxing Traditional Chinese Medicine Pieces Co., Ltd. for Atractylodes lancea (batch 170103), and Yabao Pharmaceutical Sichuan Pharmaceutical Co., Ltd. for Calcium gluconate oral solution (batch 151201). The primary violations involved the products being identified as "substandard," specifically concerning their content and properties. Operating under the regulatory oversight of the National Medical Products Administration (NMPA) framework, the Henan Provincial Food and Drug Administration mandated immediate actions. These included implementing control measures such as sealing, seizing, and suspending the sale of the affected drug batches. Furthermore, the regulatory body initiated investigations to impose penalties on the sampled entities in accordance with applicable laws and regulations. This proactive approach aims to safeguard public health and ensure compliance within the pharmaceutical industry.