China NMPA Drug Inspection - Shandong Hualu Pharmaceutical Co., Ltd. - Sodium bicarbonate injection

On December 1, 2025, the National Medical Products Administration (NMPA) of China released Announcement No. 43, identifying 35 batches of non-compliant drugs produced by 29 different companies. Testing conducted by various provincial institutes, including the Guangdong and Hebei Institutes for Drug Control, highlighted significant quality deviations across a range of pharmaceutical products. Key manufacturers cited in the report include Sichuan Tongyuan Pharmaceutical Group, Jiangsu Wanbang Biochemical Pharmaceutical, Hubei Meilin Pharmaceutical, and Sichuan Kelun Pharmaceutical. The primary violations discovered during testing included failed dissolution rates, the presence of visible foreign matter and insoluble microparticles in injectable liquids, and incorrect pH values. Additionally, some products showed excessive levels of pesticide residues, failed microbial limit tests, and insufficient biological activity. These issues pose potential risks to drug absorption, effectiveness, and patient safety. In accordance with the Drug Administration Law of the People's Republic of China, the NMPA has ordered all involved enterprises to take immediate risk control measures, including the suspension of sales and use, and the initiation of product recalls. Companies are required to investigate the root causes of these failures and implement formal rectification plans. Provincial regulatory authorities have been directed to investigate potential illegal activities and must publicly disclose the findings of these investigations to ensure transparency and regulatory compliance.