Drug repackager initiates Caraco Digoxin recall

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Drug repacking company AS Medication Solutions has issued a voluntary, consumer-level recall of all tablets of Caraco Pharmaceutical Laboratories' brand of Digoxin, USP, 0.25 mg distributed prior to March 31 and set to expire before August 2011.

The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. A lower than labeled dose may pose a risk of heart failure and abnormal heart rhythms. Consequently, as a precautionary measure, the Libertyville, Ill.-based AS Medication is recalling these tablets to the consumer level to minimize any potential risk to patients.

Caraco manufactured the tablets and has already initiated its own recall for batches USP, 0.125mg and USP, 0.25 mg distributed prior to March 31 and set to expire before September 2011. Both recalls are being conducted with the knowledge of the FDA.

Physicians should instruct consumers with AS Medication's products with the following NDC codes that are within expiration to return these products to the place of purchase:

  • Product Identification: Caraco Digoxin: AS Medication Solutions, Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with "441"
  • NDC Numbers: Digoxin Tablets, USP, 0.25 mg/54569-5758-0 (30 count)

Digoxin is used to treat heart failure and abnormal heart rhythms, and has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and a slow heart rate. Death can also result from excessive digoxin intake.