Digoxin, USP 0.25 mg

May 12, 2009

Audience: Pharmacists, cardiology healthcare professionals, consumers

AS Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. Caraco Pharmaceutical Laboratories, Ltd manufactured the recalled tablets. The recalled product is a scored round biconvex white tablet imprinted with "441", with an NDC number of 54569-5758-0 (30-count). Consumers with the product that are within expiration should return these products to their pharmacy or place of purchase.

[Posted 04/01/2009] Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall 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, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and 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. Consumers with the recalled product should return these products to their pharmacy or place of purchase.

[May 11, 2009 - Press Release - AS Medication Solutions, LLC]
[March 31, 2009 - Press Release - Caraco Pharmaceutical Laboratories, Ltd.]

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