Digoxin Manufacturing Blunders Abound

Brenda Fulmer
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Posted by Brenda FulmerApril 21, 2009 9:34 AM

Not even a year has passed since the massive recall of Digitek pills by Bertek/Mylan and Actavis, yet cardiac patients are facing yet another scare. On March 31, 2009, Caraco Pharmaceutical Laboratories, Ltd. announced a nationwide recall of all lots of its digoxin tablets due to potential manufacturing defects.The recall notice indicates that Caraco’s digoxin pills may have been manufactured at a size larger than intended, with the result being that the pills may contain an excessive dose of the active ingredient of the medication. A similar massive recall was announced by Actavis Totowa LLC, Mylan Bertek and UDL on April 25, 2008, involving millions of pills that were improperly manufactured at a facility in Little Falls, New Jersey, which has been the subject of much controversy and a Congressional inquiry.

Digoxin pills are taken by millions who have heartbeat irregularities or arrhythmias. Dosing of digoxin is extremely difficult, as the drug has a “narrow therapeutic window” and can be highly toxic when given in excess quantities. Patients suffering from digoxin or digitalis toxicity can suffer significant personal injuries and death. Digoxin toxicity can be assessed through a blood test and includes symptoms of nausea, vomiting, dizziness, cardiac instability, bradycardia, and low blood pressure.

The law firm of Searcy Denney Scarola Barnhart & Shipley represent clients who have been harmed as a result of their ingestion of improperly manufactured drugs.

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