Dangerous Digoxin Tablets Are Recalled

April 2009

Caraco Pharmaceutical Laboratories, Ltd., a generic pharmaceutical company, has announced the recall of Caraco brand digoxin. The tablets were sold in incorrect sizes and may contain too much or too little of the active ingredient digoxin, posing a health risk to patients.

Digoxin, also known as digitalis, is a medication used to treat heart failure and abnormal heart rhythms. It is often sold under the brand names Lanoxin, Digitek, and Lanoxicaps. Digoxin is derived from digitalis contained in foxglove plants and has been used for cardiac treatment since the 18th century.

The dangerous drugs were distributed prior to March 31, 2009 and have an expiration date before September 2011. Tablets that contain too much of the active ingredient may cause digoxin toxicity in patients with renal failure. This can lead to nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. In severe cases it can also lead to death. A lower than labeled dose may result in cardiac instability.

Last year, Actavis Totowa announced a similar recall for oversized lots of its Digitek tablets. Those tablets were linked to hundreds of deaths.