Eugia 一批次注射用万古霉素全国召回:批次3VM26026A、每瓶1.25克,有效期至2028年7月,瓶内发现玻璃颗粒、暂无不良事件报告

华盛顿 — 美国食品药品管理局 11 月 9 日刊登的企业通告显示,Eugia US LLC 在全国范围召回一个批次的注射用盐酸万古霉素,原因是瓶内发现一颗玻璃颗粒。
被召回产品为每瓶 1.25 克、30 毫升单剂量瓶装,批次号 3VM26026A,有效期至 2028 年 7 月。纸盒国家药品代码为 55150-471-10,每瓶代码为 55150-471-01。
该批次于 2026 年 9 月 2 日至 9 月 15 日发往全国批发商。企业于 11 月 6 日宣布召回,食品药品管理局于 11 月 9 日刊登,召回层级至医院、医疗机构与使用者层面。
食品药品管理局刊登的通告称,使用含有玻璃颗粒的产品可能造成严重不良健康后果。企业表示,截至通告时尚未收到与本次召回相关的不良事件报告。
与该产品相关的健康问题可通过食品药品管理局 MedWatch 项目在线、邮寄或传真报告。本稿只转述召回通告的事实与官方报告渠道,不作个体用药建议。
Eugia Recalls One Lot of Vancomycin for Injection Nationwide: Lot 3VM26026A, 1.25 Grams per Vial, Expiring July 2028, After a Glass Particle Was Found Inside a Vial, With No Adverse Events Reported
Washington — A company notice posted by the Food and Drug Administration on November 9 says Eugia US LLC is recalling one lot of Vancomycin Hydrochloride for Injection USP nationwide after a glass particle was found inside a vial.
The recalled product is the 1.25 gram, 30 milliliter single dose vial, lot 3VM26026A, with an expiration date of July 2028. The carton National Drug Code is 55150-471-10 and each vial carries 55150-471-01.
The lot was shipped to wholesalers nationwide from September 2 to September 15, 2026. The company announced the recall on November 6 and the FDA posted it on November 9. The recall extends to the hospital, health care facility and user level.
The notice posted by the FDA warns that use of product containing glass particulates can cause serious adverse health consequences. The company said it has received no reports of adverse events tied to the recall to date.
Health problems that may be linked to the product can be reported to the FDA MedWatch program online, by mail or by fax. This report relays only the facts in the recall notice and the official reporting channel, without individual medication advice.
发布:GSM·美国(发布链接)
图片来源:Wikipedia/Wikimedia Commons 词条主图:Lot One
GSM Global · 本篇英文版 English edition of this story

