April 6, 2009

On March 31, 2009, Caraco Pharmaceutical Laboratories Ltd (“Caraco”) announced a voluntary recall of batches of Digoxin tablets.  The recall includes batches of Digoxin distributed before March 31, 3009, which are not expired and are within the expiration date of September, 2011.  Digoxin is a generic version of GlaxoSmithKline’s Plc’s drug Lanoxin, and is used to treat heart failure and abnormal heart rhythms. 

Potential Dangers Associated with Digoxin Tablets

The company stated that the Digoxin tablets could vary in size and therefore dosage levels.  Because the tablets differ in size, they could potentially contain too much or too little of the drug’s active ingredient.  The recall was initiated because of Digoxin’s narrow therapeutic index.  While a low dosage may pose a risk of lack of efficacy resulting in cardiac instability, a high dose could lead to death.  Digoxin toxicity can result in nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia.  

Recalled Digoxin Lots

The tablets being recalled by Caraco in conjunction with the Food and Drug Administration (“FDA”) are Digoxin, USP, 0.125 mg (a scored round biconvex yellow tablet imprinted with “437”), and Digoxin, USP, 0.25 mg (a scored round biconvex white tablet imprinted with “441”).  Healthcare professionals have been notified.  Additionally, the FDA advised consumers, who are in possession of Digoxin, to return the tablets to their pharmacy or place of purchase.  

Related Recalls of Digoxin

Relatedly, in April 2008, Actavis Totowa recalled oversized Digitek tablets.  The FDA deemed that recall a Class I recall, meaning that the defective Digitek tablets posed serious health risks or death.  Between April 1 and June 30, 2007, there were 667 deaths reported to the FDA Adverse Events Reporting System involving Digitek.  Prior to the April 2008 Digitek recall, the FDA had received just one reported death attributed to Digitek.    

If you or a loved one suffered injuries caused by Digoxin, contact us today for a confidential and free case evaluation.

Published November 17, 2011 by