召回：两批次阿托伐他汀钙片混入异种药片，FDA列为二级召回
美国食品药品监督管理局（FDA）的执法报告显示，印度MSN Laboratories公司已自愿召回两批次阿托伐他汀钙片，原因是产品中混有异种药片或胶囊；FDA于10月29日把这一召回列入执法报告并定级为二级（Class II）召回，召回编号D-0113-2027。
阿托伐他汀是广泛使用的降胆固醇处方药。被召回的产品规格为阿托伐他汀钙片USP 40毫克、每瓶1,000片，仅供处方使用，国家药品代码（NDC）为72205-024-99。
涉及的两个批次是：批次DRF09618A，有效期至2029年8月31日；批次DRG02110A，有效期至2030年1月31日。瓶底或标签上的批次号可供药房与患者核对。
这批药由MSN Laboratories位于印度特伦甘纳邦的工厂生产，由新泽西州皮斯卡特韦的Novadoz Pharmaceuticals LLC在全美分销。公司于10月21日启动召回，并以信函通知客户。
二级召回是FDA的三级分类之一，意味着使用该产品可能造成暂时性、可经医疗手段逆转的不良健康后果，发生严重不良后果的可能性较低。
正在服用阿托伐他汀的患者可核对药瓶上的批次号；如属被召回批次，应联系配药药房咨询后续处理，不要自行停用处方降胆固醇药。
Recall: Two Lots of Atorvastatin Calcium Tablets Contain Foreign Tablets; FDA Classifies the Recall as Class II
According to the U.S. Food and Drug Administration's (FDA) Enforcement Report, MSN Laboratories Private Limited of India has voluntarily recalled two lots of atorvastatin calcium tablets because the product contains foreign tablets or capsules. The FDA posted the recall to its Enforcement Report and classified it as Class II on October 29, under recall number D-0113-2027.
Atorvastatin is a widely prescribed cholesterol-lowering drug. The recalled product is Atorvastatin Calcium Tablets USP, 40 mg, in 1,000-count bottles, for prescription use only, with National Drug Code (NDC) 72205-024-99.
The two affected lots are DRF09618A, expiring August 31, 2029, and DRG02110A, expiring January 31, 2030. Pharmacies and patients can check the lot number printed with the bottle.
The tablets were manufactured by MSN Laboratories at its facility in Telangana, India, and distributed nationwide in the United States by Novadoz Pharmaceuticals LLC of Piscataway, New Jersey. The firm initiated the recall on October 21, 2026, and notified customers by letter.
A Class II classification means use of the product may cause temporary or medically reversible adverse health consequences, while the probability of serious adverse health consequences is remote.
Patients taking atorvastatin should check the lot number on their bottles; anyone whose bottle is from a recalled lot should contact their pharmacy about next steps and should not stop taking a prescribed cholesterol medicine on their own.
FDA recalls and safety alerts page
来源：GSM·美国（原文链接）
图片来源：阿托伐他汀钙片（资料图）。CC BY-SA 4.0，经 Wikimedia Commons。 / Atorvastatin calcium tablets (file photo). CC BY-SA 4.0, via Wikimedia Commons.
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