
On April 28, 2008, drug manufacturer Actavis Totowa, LLC issued a Class I nationwide recall of all Digitek® Digoxin tablets distributed between March 2006 and April 2008. The pills may contain two times the acceptable dosage of the active ingredient.
On March 31, 2009, Caraco Pharmaceutical Laboratories, Ltd. and the FDA notified healthcare professionals of a recall of Caraco brand Digoxin (generic for Digitek®), 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. Likewise, on May 11, 2009, AS Medications Solutions, LLC, a drug repackaging company, announced a nationwide recall of Caraco brand Digoxin tablets, USP, 0.25 mg, which are not expired and within the expiration date of August 2011. The Caraco brand Digoxin tablets were recalled because of concerns that the tablets may have contained too much or too little of the active ingredient, Digoxin.
Class I recalls are conducted when DANGEROUS or DEFECTIVE products could cause serious health problems or death if released.Both Digoxin and Digitek® and Caraco brand Digoxin tablets are prescribed for treatment of heart failure and abnormal heart rhythms. The existence of double-strength tablets poses a risk of digitalis toxicity. This could lead to serious and potentially fatal illness caused by overmedication, especially among individuals with renal insufficiencies.
Digitalis toxicity can cause among other things:
Taking a tablet with too little Digoxin could result in cardiac instability due to lack of efficacy.
If you believe that you or a loved one has suffered hospitalization or death as a result of taking Digitek® or Caraco brand Digoxin, fill out our online form or call us toll free at 1-866-828-4699.