降压药复方片召回21,620瓶：替米沙坦含量可能超标，FDA列为三级召回
美国食品药品监督管理局（FDA）的执法报告显示，Viatris旗下Mylan制药正在自愿召回21,620瓶替米沙坦与氨氯地平复方片，规格为40毫克/5毫克、每瓶30片，原因是产品中替米沙坦含量可能超标。这批药在印度制造，召回由Mylan于10月1日发起，FDA将其列为三级召回，记录编号D-0049-2027。
涉及产品的国家药品代码（NDC）为0378-1075-93，共五个批号：3228113、3228114与3228115（有效期至2026年10月31日），以及3228120与3228121（有效期至2026年11月30日）。
替米沙坦与氨氯地平都是常用降压成分。替米沙坦摄入过量可能导致血压过低，并伴随头晕、心跳加快等症状。
三级召回是FDA召回分级中风险最低的一级，指使用或接触涉事产品不太可能造成不良健康后果。家中有这款药的患者可对照瓶身NDC与批号核对，并咨询药房或开药医生如何处理，不要自行停用降压药。
（来源：美国食品药品监督管理局执法报告）
Blood Pressure Tablets Recalled: 21,620 Bottles of Telmisartan and Amlodipine May Contain Too Much Telmisartan
Mylan Pharmaceuticals, a Viatris company, is voluntarily recalling 21,620 bottles of telmisartan and amlodipine tablets, 40 mg/5 mg in 30-count bottles, because the product may contain too much telmisartan, according to the Food and Drug Administration's Enforcement Report. The tablets were made in India, Mylan initiated the recall on October 1, and the FDA has classified it as a Class III recall under record D-0049-2027.
The recalled product carries National Drug Code (NDC) 0378-1075-93 and covers five lots: 3228113, 3228114 and 3228115, expiring October 31, 2026, and 3228120 and 3228121, expiring November 30, 2026.
Telmisartan and amlodipine are both widely used to treat high blood pressure. Taking too much telmisartan can cause low blood pressure, along with symptoms such as dizziness and a faster heartbeat.
Class III is the FDA's lowest-risk recall category, covering products whose use is not likely to cause adverse health consequences. Patients who have this medicine at home can check the NDC and lot number on the bottle and ask their pharmacy or prescriber what to do; blood pressure medication should not be stopped without medical advice.
(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：倾倒出的处方药片（资料图）。Mpelletier1 摄，CC BY-SA 3.0，经 Wikimedia Commons。 / Prescription tablets spilling from a bottle (file photo). Photo by Mpelletier1, CC BY-SA 3.0, via Wikimedia Commons.
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