Caraco Pharmaceuticals Recalls All Lots of Digoxin

Irregular Sized Tablets Pose Serious Health Threat

Caraco Pharmaceutical Laboratories, Ltd., a generic pharmaceutical company, is recalling 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 Food and Drug Administration.

Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It 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. Consequently, as a precautionary measure, Caraco is recalling these tablets to the consumer level to minimize any potential risk to patients.

The tablets being recalled are:

Caraco Digoxin 0.125 mg is a scored round biconvex yellow tablet imprinted with "437"

Caraco Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with "441"

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)

MARCH-31-09: Recall of All Lots of Digoxin Tablets Due to Size Variability [FDA: CARACO RECALLS DIGOXIN TABLETS]

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Published on Mar-31-09