ST LOUIS (MD Consult) - Caraco Pharmaceutical Laboratories has voluntarily recalled to the consumer level all tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 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 tablets were manufactured by Caraco Pharmaceutical Laboratories, Ltd. This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

Digoxin is used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index. The existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consequently, Caraco is recalling these tablets to the consumer level to minimize any potential risk to patients.

Consumers with the products with the following NDC codes that are within expiration should return these products to their place of purchase.

Product identification


 

• Caraco Digoxin 0.125 mg is a scored round biconvex yellow tablet with the number "437" printed on it;
  
   
• Caraco Digoxin 0.25 mg is a scored round biconvex white tablet with the number "441" printed on it.
  
   

NDC numbers:

Digoxin Tablets, USP, 0.125 mg—57664-437-88 (100-count), 57664-437-18 (1000-count)

Digoxin Tablets, USP, 0.25 mg—57664-441-88 (100-count), 57664-441-18 (1000-count)

Patients using Caraco's Digoxin tablets, USP, 0.125 mg or 0.25 mg, who have medical questions should contact their health care provider for additional instructions or guidance.

Retailers who have this product should return the product to their place of purchase. Retailers can call Caraco customer service at (800) 818-4555, Monday through Friday, 8:00 AM to 5:00 PM EST, for instructions on how to return the affected product or for any other inquiries related to this action.

Any adverse reactions and/or quality problems experienced with the affected product should also be reported to the FDA's MedWatch Program.

 

• Phone: Call 1-800-FDA-1088;
  
   
• Fax: Send to 1-800-FDA-0178;
• Mail: Send to Med Watch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787;
  
   
• Online: Go to the MedWatch Web site at www.fda.gov/medwatch.

圣路易斯(MD Consult)——卡拉科(Caraco)制药公司主动召回消费者手中所有2009年3月31日前出厂的0.125mg和0.25mg(美国药典)的卡拉科牌地高辛片剂，包括尚未到期或截至2011年9月到期的所有药物。

召回原因可能是这些片剂大小不一，因而造成活性成分地高辛含量不准确。这些召回的片剂由卡拉科制药有限公司生产。本次是召回在美国食品与药物管理局(FDA)的指导下进行的。

地高辛是一种治疗心力衰竭和心律失常的强心药，其治疗指数范围窄，尤其是对肾功能衰竭的患者。高于推荐剂量使用可引起地高辛中毒，出现恶心、呕吐、眩晕、低血压、心功能不稳定、心动过缓等症状，甚至导致死亡。而低于推荐剂量使用时，可导致疗效不足，可能引起心功能不稳定。因此，卡拉科公司召回上述片剂，以尽量减少病人的潜在危险。

用户应将在有效期内的国家药品编码(NDC codes)如下的产品退回购买专柜。

产品鉴别：

n       卡拉科牌地高辛 0.125mg，为圆形、双面凸、有刻痕的黄色药片，一面刻有437字样；

n       卡拉科牌地高辛 0.25mg，为圆形、双面凸、有刻痕的白色药片，一面刻有441字样。

 

国家药品编码号码：

n       地高辛片，美国药典，0.125mg—— 57664-437-88(100片装)，57664-437-18 (1000片装)；

n       地高辛片，美国药典，0.25mg——57664-441-88(100片装), 57664-441-18 (1000片装)。

 

使用卡拉科0.125mg和0.25mg地高辛片剂(美国药典)的病人如有问题应向医生寻求指导。

持有上述药品的零售商应将药品退回给供货商。零售商可以拨打卡拉科客服电话(800) 818-4555，周一至周五，8:00－17:00，可得到如何退回药品及相关问题的指导。

 

使用该药品而产生的任何不良反应，和/或质量问题也应该报告给FDA的MedWatch项目。

电话：1-800-FDA-1088; 

传真：1-800-FDA-0178;

地址：Med Watch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787；

在线：MedWatch网站 www.fda.gov/medwatch