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Digoxin Recall

A Digoxin recall was announced March 31, 2009 after discovering some of the pills may contain too much or too little of the active ingredient, digoxin. Digoxin is a generic brand of Digitek® ®, a drug designed to treat heart failure.

The recall is a consumer-level recall in which Caraco Pharmaceutical Laboratories and the U.S. Food and Drug Administration (FDA) notified healthcare professionals of a possible defect in some of the Caraco brand Digoxin tablets. The pills involved are Caraco brand Digoxin, USP, 0.125 mg and USP, 0.25 mg. The Digoxin pills that may be defective will have an expiration date that falls somewhere before September 2011.

Reason for the 2009 Digoxin Recall

According to the FDA announcement, the Digoxin pills at question may contain either too much or too little of the active ingredient, digoxin. Thus, the recall was based on a manufacturing mistake. The mistake made by the manufacturers should not be taken lightly, as a Digitek® overdose can lead to digoxin toxicity.

Digoxin Toxicity-Related Injuries

Individuals prescribed the wrong-sized Digoxin tablets are at risk of suffering Digoxin toxicity which is caused by an overdose of the active ingredient. There are several serious injuries associated with Digitek® overdose, including:

• Vomiting, nausea
• Dizziness
• Dangerously low blood pressure
• Cardiac instability
• Bradycardia (abnormally slow heart beat)
• Death

Individuals who are prescribed Digoxin pills that are too small, or contain too little of a dose of the active ingredient, are also at risk of suffering a serious injury. For instance, a patient being treated for heart failure will need a certain amount of digoxin to maintain a steady heartbeat. If their Digoxin dose is too little, however, they are at risk of heart failure.

Another Digitek® Recall

Unfortunately, this manufacture mistake is not the first of its kind. In fact, the FDA announced a Digitek® recall in April 2008 for a similar mistake. The 2008 Digitek® recall was initiated by the manufacturer, Actavis Totowa LLC based, also on a risk of toxicity following a manufacture mistakes. The recalled Digitek® pills may have contained twice the correct amount of digoxin, posing a great risk for injuries and death.

According to the FDA, Digitek® overdose is especially dangerous to patients with renal kidney impairments.

Have You Been Injured by the Recalled Digitek®?

If you or a loved one has suffered an injury or death following a Digoxin treatment, you will be eligible to seek out compensation for your losses. An experienced Digitek® attorney will thoroughly investigate your case, help you start a claim and fight aggressively to ensure you and d your family are compensated accordingly.