三联降压药溶出度不达标：3,744瓶在全美召回，FDA列为二级
美国食品药品监管局（FDA）在 10 月 26 日的执行报告中，把 Macleods Pharma USA 一款三联复方降压药的召回列为二级（Class II）。召回共涉 3,744 瓶，原因是药片未通过溶出度规格检测——溶出度衡量药片在体内溶解并释放有效成分的程度，不达标可能使药效无法按预期发挥。二级召回指使用涉事产品可能造成暂时、可逆的健康影响，出现严重后果的可能性较低。
涉事药品为奥美沙坦酯、氨氯地平与氢氯噻嗪复方片，规格 40 毫克/10 毫克/12.5 毫克，用于治疗高血压：奥美沙坦与氨氯地平帮助放松血管，氢氯噻嗪帮助身体排出多余水分。
涉事的两个批次是：30 片装，批号 12251163A，药品国家代码（NDC）33342-246-07；90 片装，批号 12251163B，NDC 33342-246-10。两批次有效期均至 2027 年 5 月 31 日，产品在全美分销。FDA 执行报告所载召回编号为 D-0077-2027。
据 FDA 执行报告，Macleods Pharma USA 于 10 月 7 日自愿发起这次召回，FDA 于 10 月 26 日完成二级分类。该公司总部位于 New Jersey 州 Princeton，涉事药片由其关联制造商在印度生产。
服用这款复方降压药的患者，可核对处方瓶或药房包装上的批号与 NDC 是否与上述信息一致；批号信息不在外包装上的，可向配药药房查询。（来源：FDA 执行报告）
Blood Pressure Drug Recall: 3,744 Bottles Pulled Nationwide After Tablets Fail Dissolution Tests
In its October 26 enforcement report, the U.S. Food and Drug Administration (FDA) classified a recall by Macleods Pharma USA of a three-in-one blood pressure medication as Class II. The recall covers 3,744 bottles and was prompted by failed dissolution specifications: dissolution testing measures how a tablet breaks down and releases its active ingredients, and a failure can mean the drug may not be absorbed as intended. A Class II recall means use of the product may cause temporary, medically reversible health consequences, while the probability of serious harm is remote.
The medication is a combination tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide, in the 40 mg/10 mg/12.5 mg strength, used to treat high blood pressure: olmesartan and amlodipine help relax blood vessels, and hydrochlorothiazide helps the body remove excess fluid.
Two lots are affected: 30-count bottles, lot 12251163A, National Drug Code (NDC) 33342-246-07; and 90-count bottles, lot 12251163B, NDC 33342-246-10. Both lots expire on May 31, 2027, and the tablets were distributed nationwide. The FDA enforcement report lists the action under recall number D-0077-2027.
According to the enforcement report, Macleods Pharma USA initiated the voluntary recall on October 7, and the FDA issued the Class II classification on October 26. The company is headquartered in Princeton, New Jersey, and the tablets were manufactured for it in India.
Patients who take this combination medication can check the lot number and NDC on their prescription packaging against the details above; where a lot number does not appear on the outer packaging, the dispensing pharmacy can confirm whether a supply is affected. (Source: FDA enforcement report)
来源：GSM·美国（原文链接）
图片来源：药片资料图（与召回药品无关）。照片：epSos.de，CC BY 2.0，经 Wikimedia Commons。
GSM Global · 本篇英文版 English edition of this story
