Macleods召回3,744瓶三合一降压药：溶出度不合格，FDA定为二级召回
美国食品药品监督管理局（FDA）的执法报告显示，Macleods Pharmaceuticals 自愿召回奥美沙坦酯、氨氯地平与氢氯噻嗪三合一降压片（40mg/10mg/12.5mg）共 3,744 瓶，原因是溶出度不合格：药物在体内释放活性成分的速率不达标，可能达不到预期的降压效果。企业已于 10 月 7 日发起召回，FDA 于 10 月 26 日将此次召回定为二级召回。
被召回的产品包括 30 片装 3,528 瓶，国家药品代码（NDC）为 33342-246-07，批号 12251163A；以及 90 片装 216 瓶，NDC 为 33342-246-10，批号 12251163B。两批产品的有效期均至 2027 年 5 月 31 日。
按 FDA 的分级，二级召回意味着使用该产品可能造成暂时或医学上可逆的健康影响，发生严重健康问题的可能性较低。FDA 没有就此次召回单独发布新闻稿，执法报告显示企业已发出通知信，告知可能持有这批药品的商家与个人。
这款三合一片是品牌药 Tribenzor 的仿制药。品牌原研药 Tribenzor 本身不在此次召回之列，服用该仿制药的患者可凭药瓶标签上的 NDC 编号与批号核对自己手中的药品是否在召回范围内。
Macleods Recalls 3,744 Bottles of Triple-Combination Blood Pressure Tablets Over Dissolution Failure
Macleods Pharmaceuticals is voluntarily recalling 3,744 bottles of its olmesartan medoxomil, amlodipine and hydrochlorothiazide triple-combination blood pressure tablets (40 mg/10 mg/12.5 mg) because the product failed dissolution specifications, meaning it does not release its active ingredients at the proper rate in the body and may not lower blood pressure as expected, according to the Food and Drug Administration's enforcement report. The company initiated the recall on October 7, and the FDA classified it as a Class II recall on October 26.
The recall covers 3,528 bottles in the 30-count size, National Drug Code (NDC) 33342-246-07, lot 12251163A, and 216 bottles in the 90-count size, NDC 33342-246-10, lot 12251163B. Both lots expire on May 31, 2027.
Under the FDA's classification, a Class II recall means use of the product may cause temporary or medically reversible adverse health consequences, while the probability of serious health problems is low. The FDA did not issue a separate news release for this recall; its enforcement report says notification letters were sent to businesses and people who may have the medication.
The tablets are a generic version of the brand-name drug Tribenzor. Brand-name Tribenzor itself is not part of the recall, and patients taking the generic can check the NDC and lot numbers on their bottle labels to see whether their medication is included.
发布：GSM·美国（发布链接）
图片来源：各式药片（资料图）。Pöllö 摄，CC BY 3.0，经 Wikimedia Commons。 / Assorted tablets (file photo). Photo by Pöllö, CC BY 3.0, via Wikimedia Commons.
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