May 12, 2009

Some Caraco-brand digoxin tablets recalled

The U.S. Food and Drug Administration says some Caraco-brand digoxin 0.25 milligram tablets distributed before March 31 were recalled due to a safety hazard.

The FDA said A S Medication Solutions LLC announced the tablets, which have an expiration date of August 2011, might differ in size and therefore could have more or less of the active ingredient.

The tablets were manufactured by Caraco Pharmaceutical Laboratories Ltd.

Digoxin is used to treat heart failure and abnormal heart rhythms, the FDA said, and the existence of a 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 slow heart rate. Death can also result from excessive digoxin intake.

A lower than labeled dose might pose a risk of heart failure and abnormal heart rhythms, the federal agency said.

Consumers with the products that have NDC No. 54569-5758-0 and are scored, round biconvex tablets imprinted with the number 441 are advised to return the medication to the place of purchase.