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On April 25, 2008, the United States Food and Drug Administration (FDA) issued a Digitek® (digoxin) recall, based on information that double-dosage pills may have distributed throughout the United States. The personal injury attorneys at The Locks Law Firm have handled many claims involving dangerous or defective drugs, including Digitek®. Contact our law firm serving New York, New Jersey, and Pennsylvania if you or a loved one has taken Digitek®. Our lawyers can explain your legal rights during a free consultation and help you pursue the compensation you deserve.
Digitek® is a brand name of a type of cardiac glycoside, which encompasses a group of drugs that affect the myocardium of the heart. Digitek® is widely prescribed to treat various heart conditions, including arterial flutter and congestive heart failure, and is used by a many people throughout the tri-state area.
People now taking Digitek® should not stop taking it without first consulting with a physician. You should also not throw away or lose possession of any Digitek® pills you currently have. If you or a loved one is taking Digitek® and you are concerned about the recall, contact the attorneys at The Locks Law Firm for assistance.
An overdosage of Digitek® may cause toxicity with life-threatening side effects, including ventricular fibrillation, ventricular tachycardia, or progressive bradyarrhythmias, or heart block. An overdosage can also be fatal.
The FDA issued a Warning Letter on August 15, 2006, to the manufacturer of Digitek®, citing a failure to file periodic safety reports. The FDA's letter also warned that procedures for the surveillance, receipt, evaluation, and report of adverse events were not developed.
A revised Warning Letter was issued by the FDA on February 1, 2007, citing “significant deviations from the current Good Manufacturing Practice regulations.” It specified deficiencies in the operation of the firm's quality control unit and warned of a failure to adequately investigate and resolve laboratory deviations.
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 announced a Class I recall of all lots of Mylan Bertek Pharmaceuticals, Inc., and UDL Laboratories, Inc., Digitek® on April 25, 2008. The Digitek® recall was based on information that certain lots of Digitek® that were distributed in the United States may have contained double-dosage pills. Class I is the most serious type of FDA recall and is only issued when there exists a reasonable probability that serious injury or death could occur from use of the product.
The Locks Law Firm has filed a class action in New Jersey state court to assist people who have taken Digitek® in receiving:
The Locks Law Firm has also filed personal injury lawsuits on behalf of individuals in New Jersey who have been injured or who have suffered the death of a loved one due to the ingestion of the double-dosage Digitek® pills.
At the Locks Law Firm, our attorneys are highly experienced in litigating pharmaceutical cases. If you or a loved has taken Digitek®, our lawyers can help. Our attorneys are ready to take action against these big pharmaceutical companies to help you obtain the compensation to which you are entitled. Contact the dangerous drug attorneys at our New York, New Jersey, and Pennsylvania offices for a consultation regarding your Digitek® case. Our lawyers are ready to help.
Contact our New York, New Jersey, or Pennsylvania Digitek® lawyers to schedule a free consultation and case evaluation.