ST LOUIS (MD Consult) - On May 12, 2009, the US Food and Drug Administration announced that A-S Medication Solutions, LLC, a drug repackage company, is voluntarily recalling all tablets of Caraco brand Digoxin 0.25-mg tablets that were distributed before March 31, 2009, and that are not expired and are within the expiration date of August 2011. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. The recalled product is a scored, round, biconvex white tablet imprinted with "441" and has a National Drug Classification number of 54569-5758-0 (30-count).

Digoxin is used to treat heart failure and cardiac arrhythmias. The drug has a narrow therapeutic index, and taking a higher-than-labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, hypotension, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. Taking a lower-than-labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability.

Consumers with the recalled products are being directed to return them to their pharmacy or place of purchase. Any adverse reactions experienced with the use of the affected products should be reported to the FDA's MedWatch Adverse Event Reporting program online, by telephone (1-800-FDA-1088), or by sending the postage-paid FDA form 3500 by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or by fax to 1-800-FDA-0178.

圣路易斯(MD Consult) ——2009年5月12日，美国食品药品管理局宣布，药品再包装公司A-S Medication Solutions, LLC自愿召回2009年3月31日前售出的所有Caraco牌地高辛 0.25mg片剂，此批片剂尚未到期，效期截止至2011年8月。召回原因为，片剂大小不一，故活性成分地高辛的含量不确定。召回的地高辛是有刻痕的、圆形、双面凸的白色片剂，带有“441”刻印，其国家药品分类号为54569-5758-0。

地高辛用于治疗心力衰竭和心律失常。该药的治疗窗较窄，肾功能衰竭患者服用该药的剂量高于标注剂量时可能会有发生地高辛毒性的危险。地高辛毒性可引起恶心、呕吐、眩晕、低血压、心脏不稳定以及心动过缓。过量服用地高辛亦可导致死亡。服用的剂量低于标注剂量时可能会产生药效不足，进而导致心脏不稳定。

目前公司正指导手中有召回产品的客户将产品退回药房或购买处。因使用此问题产品而产生的任何不良反应均应报告至FDA 的MedWatch不良事件报告项目（FDA's MedWatch Adverse Event Reporting program），可在线上报，亦可致电（1-800-FDA-1088)上报，或将邮资已付的FDA 3500表格（FDA form 3500）邮寄至以下地址：MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787，或发传真至1-800-FDA-0178。

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