FDA expands recall on Caraco brand digoxin medication

posted on:
May 13, 2009


The Food and Drug Administration (FDA) and AS Medications Solutions LLC announced a nationwide recall of all lots of the 0.25 mg. heart medication digoxin manufactured by Caraco Pharmaceuticals Laboratories distributed prior to March 31, 2009 because they may differ in size and therefore may contain more or less of the active ingredient.

This action follows an alert issued by the company for the Caraco brand Digoxin, USP, 0.125 mg and the Digoxin, USP, 0.25 mg tablets, both distributed prior to 2009. That recall included both 100-count and 1,000-count tablets of both mgs. The latest recall adds the 20-count 0.25 mg tablet to the recall.

Product included in the recall NDC numbers are:

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)

Digoxin is used to treat heart failure and abnormal heart rhythms. 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, bradycardia and death. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability.

Last year, Actavis Totowa LLC, a generic pharmaceutical company initiated a Class 1 recall on Digitek brand digoxin tablets when it was learned that some tablets were oversized and contained twice the level of active ingredient, putting consumers at risk.

Consumers of Caraco’s digoxin tablets that fall within the recall should return these products to their pharmacy or place of purchase. Patients who have medical questions should contact their health care provider for additional instructions or guidance.

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