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Another Digoxin Tablet Recall

May 13, 2009 | Parker Waichman LLP

More defective generic Digoxin tablets made  by Caraco Pharmaceutical Laboratories, Ltd. have been recalled.  According to the Food & Drug Administration (FDA), the recall was initiated by A-S Medication Solutions, LLC, a drug repackage company.

This past March, Caraco Pharmaceuticals issued a recall of several lots of Digoxin tablets it had made.  Today's recall, and the one ordered in March were issued because there was a chance that the Digoxin  tablets involved  differed in size and therefore could contain too much or too little of the drug’s active ingredient.

Digoxin is a drug used to treat heart failure and abnormal heart rhythms. According to the FDA, it has a narrow therapeutic index and the existence of a 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 bradycardia. Death can also result from excessive Digoxin intake.

A lower than labeled dose may lack efficacy, potentially resulting in cardiac instability.

Today's recall of Caraco-brand Digoxin tablets includes all 0.25 mg tablets distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011.  The recalled Digoxin tablets involve those bearing NDC Number 54569-5758-0 (30-count).

Consumers or healthcare providers with these recalled Digoxin tablets should return them to the place of purchase. Patients using A-S Medication Solutions, Digoxin tablets, USP, 0.25 mg, who have medical questions should contact their healthcare provider for additional instructions or guidance.

Healthcare providers can call the A-S Medication Solutions Recall Coordinator at (847) 680-3515, Monday through Friday, 8:00 a.m. – 4:00 p.m. CST, for instructions on how to return the affected product or for any other inquiries related to this action.


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