Macleods一款复方降压药3744瓶召回定级为二级：涉两批次、有效期至2027年5月31日，企业10月7日发起、食药局10月26日定级
华盛顿 — 据报道美国食品药品管理局召回信息的媒体汇总，Macleods Pharma USA 公司一款奥美沙坦酯、氨氯地平与氢氯噻嗪复方片剂共 3744 瓶被召回，该局已把召回定级为二级。
受影响产品包括 30 片装 3528 瓶，批次号 12251163A，国家药品代码为 33342-246-07，以及 90 片装 216 瓶，批次号 12251163B，国家药品代码为 33342-246-10。两批次的有效期均为 2027 年 5 月 31 日。
召回由企业于 10 月 7 日自愿发起，食品药品管理局于 10 月 26 日定级，产品在全美分发。
报道说明，本次召回只限上述两个批次，不适用于这款复方药的每一瓶或其它降压药。本稿只转述召回信息中的产品与批次事实，不作个体用药建议，核对以食品药品管理局召回记录与药瓶包装信息为准。
Macleods Combination Blood Pressure Tablets Recalled in 3,744 Bottles Classified as Class II: Two Lots Expiring May 31, 2027, Initiated by the Company on October 7 and Classified by the FDA on October 26
Washington — According to media reporting of Food and Drug Administration recall information, Macleods Pharma USA is recalling 3,744 bottles of olmesartan medoxomil, amlodipine and hydrochlorothiazide combination tablets, and the FDA has classified the action as a Class II recall.
The affected product includes 3,528 bottles of 30 tablets, lot 12251163A, National Drug Code 33342-246-07, and 216 bottles of 90 tablets, lot 12251163B, National Drug Code 33342-246-10. Both lots expire on May 31, 2027.
The company initiated the voluntary recall on October 7, the FDA classified it on October 26, and the bottles were distributed nationwide in the United States.
The reporting states the recall is limited to the two identified lots and does not apply to every bottle of this combination drug or to other blood pressure medications. This report relays only the product and lot facts in the recall information, without individual medication advice, and checking should rely on the FDA recall record and bottle packaging.
发布：GSM·美国（发布链接）
图片来源：食品药品监督固定图库（GSM asset-packs）
GSM Global · 本篇英文版 English edition of this story
