China NMPA Drug Inspection - Hunan Xiangyikang Pharmaceutical Co., Ltd. - Sodium cefamandole for injection

The State Food and Drug Administration (SFDA) announced on January 13, 2016, findings from national drug sampling inspections revealing multiple batches of non-compliant products from four pharmaceutical companies. The implicated companies are Haikou Pharmaceutical Factory Co., Ltd., Hainan Lingkang Pharmaceutical Co., Ltd., Anhui Tongtai Pharmaceutical Co., Ltd., and Jiangxi Minji Pharmaceutical Co., Ltd. Main violations included Haikou Pharmaceutical Factory's cefamandole sodium for injection failing identification, pH, and content determination. Hainan Lingkang Pharmaceutical had cefamandole sodium for injection batches failing clarity, color, and volume variation, and meclofenac hydrochloride for injection batches failing fill weight variation and content determination. Anhui Tongtai and Jiangxi Minji Pharmaceutical both had multiple batches of gynecological anti-leukorrhea tablets failing content determination. These widespread deficiencies indicate systemic issues in the companies' quality management and production process control. Under the SFDA's directive, provincial Food and Drug Administrations were mandated to oversee immediate actions. These actions include ordering the companies to suspend sales, recall all substandard products, and conduct thorough investigations into the root causes of the quality failures. Furthermore, companies must halt production of the affected items, develop and implement effective rectification measures, and publicly disclose all relevant recall and investigation information. Local regulatory bodies are responsible for supervising distributors and users to ensure the prompt removal and sealing of non-compliant drugs, aiding in the recall process.