Digitek Heart Drug Recalled after FDA Warning
Digitek® is the brand-name of one of the cardiac glycosides, a group of drugs having specific effects on the myocardium of the heart. Digitek® is widely prescribed and used by a great number of residents of New Jersey, Pennsylvania, New York, and elsewhere to treat various heart conditions, including atrial flutter and congestive heart failure. On August 15, 2006, the FDA issued a letter warning about failing to file periodic safety reports. The FDA's August 2006 Warning Letter also warned about not developing procedures for the surveillance, receipt, evaluation and report of adverse events. On February 1, 2007, the FDA issued a revised Warning Letter citing "significant deviations from the current Good Manufacturing Practice regulations." According to the FDA's Revised Warning Letter:"Significant deficiencies were found in the operations of your firm's quality control unit, and as a result there is no assurance that many drug products manufactured and released into interstate commerce by your firm have the identity, strength, quality and purity that they purport to possess."
The FDA's Revised Warning Letter cited deficiencies in the operations of the quality control unit, where the unit failed to adequately investigate and resolve laboratory deviations. On April 25, 2008, the United States Food and Drug Administration announced a Class I Recall of all lots of Bertek and UDL Laboratories Digitek® (hereinafter "recalled Digitek®"). Class I Recalls are instituted only when there exists a reasonable probability that use of the product will cause serious injury or death. The recall was based on information that there may have been a double dosage of Digitek in certain lots distributed in the United States. Over dosage of Digitek may cause life-threatening toxicity including ventricular tachycardia or ventricular fibrillation, or progressive bradyarrhythmias, or heart block. It may cause death.
Locks Law Firm LLC has filed a Class Action in state court in New Jersey to assist persons who took Digitek (a) in receiving proper notice of whether they ingested the double-dosage or not, and (b) in receiving information about the risks, and ( c) in being compensated for medical bills incurred in evaluating whether or not they were injured and (d) for reimbursement of purchase price.
Locks Law Firm has also filed individual personal injury lawsuits in New Jersey for persons actually injured or killed by ingesting the double dosage of Digitek.
If you or a loved one has taken Digitek you should NOT cease taking it without discussing the matter with your physician. You should NOT lose possession of any Digitek which you currently have. If you would like to know your legal rights please feel free to contact us for a free consultation.
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