召回：49,488瓶西那卡塞片溶出度不合格，FDA列为二级召回，仅涉一批次
美国食品药品监督管理局（FDA）10月28日一期的执法报告显示，Strides Pharma公司已自愿召回49,488瓶西那卡塞片，原因是产品未通过溶出度检测；FDA把这一召回定级为二级（Class II）。
西那卡塞用于治疗慢性肾病等患者的甲状旁腺激素异常。被召回的只有一批次：规格为30毫克的西那卡塞片，批次号7717825A，有效期至2028年11月。
溶出度检测衡量药片在体内按预期速度崩解、溶出并被吸收的程度；溶出度不合格的药片可能无法按设计释放有效成分，从而降低疗效。
召回由总部位于新泽西州布里奇沃特的Strides Pharma于10月7日启动，FDA于10月26日完成二级定级。公司以信函方式通知客户，未另行发布新闻稿。
二级召回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。
药房应核对库存、隔离涉事批次并按公司通知处理；正在服用西那卡塞的患者可核对药瓶批次号，如属被召回批次，应联系药房或开药医生咨询替换，不要自行停药。
Recall: 49,488 Bottles of Cinacalcet Tablets Fail Dissolution Specifications; FDA Class II Recall Covers a Single Lot
The U.S. Food and Drug Administration's (FDA) Enforcement Report dated October 28 shows that Strides Pharma, Inc. has voluntarily recalled 49,488 bottles of cinacalcet tablets because the product failed dissolution specifications. The FDA classified the recall as Class II.
Cinacalcet is used to treat parathyroid hormone disorders in patients including those with chronic kidney disease. Only one lot is affected: cinacalcet tablets, 30 mg, lot 7717825A, expiring in November 2028.
Dissolution testing measures whether a tablet breaks down and releases its active ingredient at the intended rate so it can be absorbed. Tablets that fail dissolution specifications may not release the drug as designed, reducing the treatment's effectiveness.
Strides Pharma, based in Bridgewater, New Jersey, initiated the recall on October 7, 2026, and the FDA assigned the Class II classification on October 26. The company notified customers by letter and issued no separate press release.
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.
Pharmacies should check inventory, quarantine the affected lot and follow the company's instructions. Patients taking cinacalcet can check the lot number on their bottles and, if it matches, contact their pharmacy or prescriber about a replacement rather than stopping the medicine on their own.
FDA recalls and safety alerts page
来源：GSM·美国（原文链接）
图片来源：处方药胶囊（资料图）。CC BY 2.0，经 Wikimedia Commons。 / Prescription capsules (file photo). CC BY 2.0, via Wikimedia Commons.
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