国家药监局通告37批次药品不符合规定

国家药监局日前发布药品质量通告，经5家药品检验机构检验，共有13家企业生产的37批次药品不符合规定1。不符合规定的药品涉及多个品种，其中妥布霉素地塞米松滴眼液23批次、丙酸氟替卡松乳膏4批次、远志6批次、款冬花3批次、盐酸胺碘酮注射液1批次1。检测不符合项目包括pH值、粒度、无菌及黄曲霉毒素等1。

药品监督管理部门已要求相关企业采取暂停销售使用、召回等风险控制措施1。相关省级药品监督管理部门依据《中华人民共和国药品管理法》组织立案调查1。

China's National Medical Products Administration has announced that 37 batches of medications produced by 13 enterprises failed to meet regulatory standards following inspections conducted by five drug testing institutions 1. The non-compliant products include fluticasone propionate cream, tobramycin dexamethasone eye drops, and amiodarone hydrochloride injection, among others, with defects ranging from improper pH levels and particle size to sterility failures and aflatoxin contamination 1.

The specific violations involved four batches of fluticasone propionate cream with pH value deviations, 23 batches of tobramycin dexamethasone eye drops, one batch of amiodarone hydrochloride injection, three batches of coltsfoot herb, and six batches of Chinese senega root 1. In response, the drug regulatory authorities have mandated that the responsible enterprises immediately suspend sales, recall the affected batches, and implement corrective measures 1. Provincial drug supervision departments have initiated formal investigations in accordance with China's drug administration law 1.