China NMPA Drug Inspection - Shaanxi Xiyue Pharmaceutical Co., Ltd. - Phenytoin sodium tablets

The State Food and Drug Administration (SFDA) of China issued its 4th National Drug Quality Bulletin of 2007 on March 18, 2008, following evaluative sampling inspections conducted in 2007. These inspections aimed to strengthen drug supervision and ensure public safety across drug distribution enterprises and medical institutions nationwide.The SFDA assessed 7,619 batches of 238 drug varieties from 1,528 manufacturers. The findings revealed that 25 batches across 11 varieties from 15 manufacturers were substandard. Specifically, 21 pharmaceutical companies had 21 batches of 10 products fail quality tests, and 4 medical institutions had 4 batches of 2 products fail. Common violations included failures in dissolution rates (e.g., Cimitidine, Acetaminophen, Phenytoin Sodium), incorrect content determination (e.g., Erythromycin, Shuanghuanglian, Gentamicin Sulfate), unacceptable levels of free salicylic acid or issues with release rate (Aspirin Enteric-coated Tablets), total ash content (Shumi Capsules), and disintegration time (Compound Aluminum Hydroxide Tablets). Noteworthy manufacturers with multiple issues included Henan Huali Pharmaceutical Co., Ltd. and Shanxi Yunpeng Pharmaceutical Co., Ltd.Regulatory actions require provincial drug authorities to address these non-compliances according to the Drug Administration Law and other relevant regulations. Furthermore, follow-up sampling inspections of the substandard varieties must be conducted, with handling results submitted to the SFDA by September 30, 2008. This initiative underscores China's commitment to maintaining drug quality and safety standards.