Recalls of Digoxin and Propafenone Tablets (June 2009)

FDA has posted information about two cardiac drugs that were recently recalled because of variability in the size of the tablets:

• Caraco Pharmaceutical Laboratories, a manufacturer of generic pharmaceuticals, recalled some of their digoxin tablets. Included in the recall are 0.125 and 0.25 mg tablets that were distributed prior to March 31, 2009 and which show an expiration date of September, 2011.

Because of the variation in tablet size, these products could contain either more or less than the labeled amount of digoxin. Digoxin has a narrow therapeutic index, which means that small variations in tablet potency could have serious effects. Too much of the drug can cause digoxin toxicity, which can include hypotension and cardiac instability and may lead to death. Too little can lessen the drug's effectiveness, which can also lead to cardiac instability.

• Watson Pharmaceuticals recalled one lot of 225 mg propafenone HCL tablets, packaged in bottles of 100, because they may contain slightly more than the labeled amount of the drug. The recalled tablets show an expiration date of July 31, 2010. Like digoxin, propafenone has a narrow therapeutic index, and too much of the drug can cause hypotension and arrhythmias.

Patients and providers should report problems they encounter with any of these recalled products to FDA's MedWatch program.

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Education

Tags:

• Digoxin
• Propafenone
• Recall
• Cardiac Drugs
• FDA
• Hypotension
• Cardiac Instability
• Patient Safety
• Arrhythmias