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

On September 11, 2017, the Henan Provincial Food and Drug Administration, operating under the regulatory framework of China's National Medical Products Administration (NMPA), announced that three batches of drugs from distinct manufacturers were found to be substandard. This discovery followed testing conducted by the Luoyang Municipal Food and Drug Inspection Institute of Henan Province. The companies involved were Hainan Haishen Tongzhou Pharmaceutical Co., Ltd., with substandard 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 identified pertained to the content and properties of these drug batches, indicating they did not meet required quality specifications. In response, the Henan Provincial Food and Drug Administration mandated immediate actions, including the sealing, seizing, and suspension of sales for the affected drugs. Additionally, investigations were initiated to ensure legal punishment for the responsible parties, demonstrating a commitment to enforcing drug quality and patient safety standards.