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May 19, 2009: Caraco Pharmaceuticals Recalls All Lots of Digoxin Tablets Due to Size Variability

On March 31, 2009, Caraco Pharmaceutical Laboratories issued a drug recall for its digoxin tablets due to tablet size variability.  Variation in tablet size could expose patients to digoxin doses that either exceed or are below the labeled therapeutic dosage.

The following digoxin tablets are subject to the recall: 

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. 

Product Identification: 

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” 

Digoxin, the generic term for thE medication, is prescribed to patients for the treatment of heart failure and abnormal heart rhythms. 

Digoxin has a narrow therapeutic index, or more simply put; there is a very narrow range between the dosage that can help patients and the dosage that can be toxic to patients.  Variability is tablet size could therefore expose patients to too little or too much digoxin. 

Symptoms of digoxin toxicity may include nausea and vomiting, dizziness, low blood pressure, cardiac instability, bracycardia (slow heart rate), and death.  Conversely, patients receiving less than the labeled dose of digoxin are at risk for a lack of drug efficacy, which can result in cardiac instability. 

Consumers should not use the recalled digoxin tablets, and should direct questions to their health care provider. 

The FDA advises that adverse reactions experienced with the use of the recalled digoxin tablets should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, or on the MedWatch website at 

If you or a family member was injured as a result of a recalled drug product, please submit a Free Case Evaluation Form, or call us toll free at 1-877-934-6274. Since 1984, the Law Firm of Eric H. Weinberg has represented hundreds of individuals injured by dangerous and defective drug products.  The firm has played a leading role in the litigation of high-profile drug lawsuits including Vioxx, Baycol, and blood products, recovering over $700 million on behalf of the firm's clients.  

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