Digoxin Drug Recall Issued by AS Medications Solutions

On May 11, 2009, the FDA posted notice of a digoxin drug recall issued by A S Medication Solutions, LLC, a drug repackaging company who distributed .25mg tablets manufactured by Caraco Pharmaceutical Laboratories, Ltd. The tablets could contain too much or too little of the drug, potentially increasing the risk of digoxin toxicity.

Digoxin is a generic heart medication used to treat abnormal heart rhythms, atrial flutter, atrial fibrillation and heart failure.

It is a very dose-specific medication, which means that receiving more or less than the prescribed doses could lead to serious and potentially life threatening side effects. If too little medication is contained in a tablet, the medication may be ineffective at treating the underlying condition. If too much of the medication is contained in a tablet, digoxin could build up in the body and become toxic.

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Digoxin toxicity can cause cardiac instability, slow heart rate, low blood pressure, dizziness, nausea and vomitting. The problems most commonly occur among individuals with renal faiilure.

A Caraco digoxin recall was issued on March 31, 2009, for all lots of 0.125 mg tablets (which are round and yellow with an imprint of “437”) and 0.25 mg tablets (which are round and white with an imprint of “441”). The tablets were sold in 100-count and 1000-count bottles.

According to the new digoxin drug recall notice issued yesterday by A S Medication Solutions, LLC, the drug repackager indicates that they distributed 0.25 mg tablets manufactured by Caraco, which also may vary in size.

A S Medication Solutions is recalling all 0.25 mg tablets distributed prior to March 31, 2009, which are not expired and within the expiration date of August 2011. The digoxen tablets were sold in 30-count bottles (NDC Number 54569-5758-0).

A similar digoxin recall was issued last year by Actavis Totowa after manufacturing problems and inadequate quality controls resulted in the distribution of tablets sold under the Digitek brand name that contained up to double the appropriate amount of the drug.

The Center for Public Integrity issued a report in December 2008, indicating that at least 667 digoxin drug deaths were reported to the FDA between April 2008 and June 2008 where extra strength Digitek tablets were identified as the “primary suspect.”

Actavis Totowa currently faces potentially substantial liability for serious and fatal injuries suffered by users who have filed a Digitek lawsuit alleging that they received extra strength tablets.

At this time, it is unknown how many users of digoxin distributed by Caraco or A S Medication Solutions may have actually used tablets that contained an inappropriate dose. No reported generic digoxin lawsuits have been filed as a result of the A S Medication Solutions or Caraco recalls.


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