Life Sciences

Caraco recalls Digoxin tablets

Pharma Compliance Alert, April 8, 2009

Caraco Laboratories issued a recall for its Digoxin tablets because they may differ in size and therefore could have more or less of the active ingredient, according to an FDA release.

Physicians use digoxin to treat heart failure and abnormal heart rhythms. A higher than labeled dose may lead to digoxin toxicity in patients with renal failure, the FDA said. A lower than labeled dose may not be effective, potentially resulting in cardiac instability.

Caraco is recalling Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, that are not expired and are within the expiration date of September 2011.