China NMPA Drug Inspection - Zhejiang Hisun Pharmaceutical Co., Ltd. - Latamoxef sodium for injection

The National Medical Products Administration (NMPA) released an announcement on July 20, 2018, detailing significant quality and safety deviations across 14 batches of drugs produced by 13 different manufacturers. The inspections, conducted by six drug testing institutions, revealed various non-compliance issues with national drug standards. Prominent violations included Shaanxi Hanwang Pharmaceutical Co., Ltd.'s Muxiang Shunqi Pills and several batches of Qianghuo from multiple companies failing appearance standards. Jiangxi Decheng Pharmaceutical Co., Ltd.'s Compound Dexamethasone Acetate Cream, along with other products, exhibited issues with content determination and fill volume. Solubility was compromised in Shilintong Granules by Sichuan Ziren Pharmaceutical Co., Ltd., while Jianmin Pharmaceutical Group Co., Ltd.'s Xiaojin Capsules exceeded microbial limits. Furthermore, Chifeng Weikang Biochemical Pharmaceutical Co., Ltd. and Gansu Xifeng Pharmaceutical Co., Ltd. had content determination problems with Vitamin U Belladonna Aluminum Capsules, and Zhejiang Huidisen Pharmaceutical Co., Ltd.'s Latamoxef Sodium for Injection showed elevated related substances. These failures contravene standards outlined in the Pharmacopoeia of the People's Republic of China and other national regulations. As a result, authorities initiated immediate control measures including product recalls, sales suspensions, and seizures. The NMPA directed provincial drug regulatory bodies to investigate these entities for producing and distributing substandard drugs, citing Articles 73, 74, and 75 of the Drug Administration Law of the People's Republic of China. These investigations are mandated for completion, with public disclosure of findings, within three months, underscoring a commitment to consumer safety and regulatory enforcement.