Ascend召回11,424瓶氨氯地平奥美沙坦片：溶出度不合格，FDA列为二级召回
美国食品药品监督管理局（FDA）的执法记录显示，Ascend Laboratories正在召回氨氯地平与奥美沙坦酯复方片（10毫克/40毫克），共11,424瓶，原因是溶出度不合格：药片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。FDA将此次召回列为二级召回，召回日期为10月16日。
被召回的是一个批号的产品：30片装，国家药品代码（NDC）为67877-502-30，批号25120696，有效期至2026年12月31日。产品由印度的Alkem Laboratories制造。
氨氯地平与奥美沙坦是两种常用降压成分，这款复方片是品牌药Azor的仿制药。品牌药本身不在此次召回之列。
按FDA分级，二级召回意味着使用涉事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。服用这款仿制药的患者可对照药瓶上的NDC编号与批号确认是否在召回范围内。
这是今年10月以来FDA执法记录中又一起降压复方药因溶出度问题被召回的案例；此前Macleods公司的一款三合一降压片也因同样原因被列为二级召回。
（来源：美国食品药品监督管理局执法报告）
Ascend Recalls 11,424 Bottles of Amlodipine and Olmesartan Tablets Over Dissolution Failure, an FDA Class II Recall
Ascend Laboratories is recalling its amlodipine and olmesartan medoxomil tablets (10 mg/40 mg), a total of 11,424 bottles, because the product failed dissolution specifications, meaning it does not release its active ingredients at the proper rate and may not lower blood pressure as expected, according to the Food and Drug Administration's enforcement records. The FDA classified the recall as Class II, dated October 16.
The recall covers a single lot: 30-count bottles with National Drug Code (NDC) 67877-502-30, lot 25120696, expiring December 31, 2026. The tablets were manufactured by Alkem Laboratories in India.
Amlodipine and olmesartan are both widely used blood pressure medicines, and the combination tablet is a generic version of the brand-name drug Azor. The brand-name product is not part of this recall.
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. Patients taking the generic can check the NDC and lot number on their bottle labels to see whether their medication is included.
It is the latest in a run of blood pressure combination tablets recalled over dissolution failures in the FDA's October enforcement records; a triple-combination tablet from Macleods was classified Class II for the same reason earlier in the season.
(Source: U.S. Food and Drug Administration Enforcement)
来源：美国食品药品监督管理局执法报告
发布：GSM·美国（发布链接）
图片来源：泡罩包装中的药片（资料图）。佚名 摄，CC0，经 Wikimedia Commons。 / Tablets in a blister pack (file photo). Photo: unknown, CC0, via Wikimedia Commons.
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