The makers of Digitek and its generic form, Digoxin, continue to have problems with their manufacturing processes. Several months ago, we first reported that a number of lots of the 0.125 mg Digitek tablets had been recalled by Actavis and Mylan, the makers and marketers of the drug. Subsequently, Actavis and Mylan did a total recall of the tablets manufactured in its plant in New Jersey, including the 0.25 mg dosage.
More recently, Caraco Pharmaceutical Laboratories, LTD, and AS Medication Solutions, LLC, the manufacturer and packager of the Caraco brand of Digoxin, the generic form of Digitek, recalled both its 0.125 and 0.25 mg pills because, like Digitek, some of the pills contained too much or too little of the drug’s active ingredient. These recalls occurred on March 31st and May 12, 2009. The March 31, 2009 FDA Recall notice provides:
Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. 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 pose a risk of lack of efficacy potentially resulting in cardiac instability….
Our firm is reviewing Digitek and Digoxin cases. If you need more information, you should contact Ben Locklar at 800-898-2034 or by email at Ben.Locklar@beasleyallen.com.
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