Urgent Digitek Recall
April 25, 2008
On April 25, 2008, a nationwide recall was issued for all strengths of Digitek, a prescription drug used to treat heart failure and abnormal heart rhythms. According to Actavis Totowa LLC, Digitek’s maker, a manufacturing defect may have caused double-strength Digitek tablets to be released to the public. The Digitek recall effected Digitek tablets are distributed by Mylan Pharmaceuticals Inc. under a “Bertek”? label and by UDL Laboratories, Inc. under a “UDL” label.
The Digitek recall is a class I recall, which is the most urgent recall the FDA can issue. A class I recall means that the defective Digitek tables could cause serious health problems or death. Although little else is known about the scope of the Digitek problems, it is estimated that up to 50 percent of the Digitek currently on the market could contain a dangerous double-dose.
Because the active ingredient in Digitek is poisonous if taken in excess, the recalled double-strength Digitek pills are extremely dangerous. In fact, recall information posted on the FDA website states that double-strength Digitek pills pose a risk of digitalis toxicity, a potentially fatal condition caused by Digitek overdose. Early symptoms of digitalis toxicity may include nausea, vomiting, diarrhea, abdominal pain, hallucinations, delirium, cardiac instability, low blood pressure, and severe headache.
Both Actavis and the FDA have announced that retailers who have Digitek tablets in stock should return the product to the manufacturer. Consumers with medical questions should contact their health care providers. Additionally, consumers can obtain more information on the Digitek recall by calling the Stericycle customer service line at 1-888-276-6166. Additional information about the Digitek recall can also be found at the Actavis Website at: www.actavis.us. The FDA has urged anyone suffering from digitalis toxicity after taking Digitek to make a report to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Finally, if you or a loved one has suffered an injury that you suspect is associated with Digitek, or any other medication, you may be entitled to compensation for your injuries. Our Digitek injury lawyers can confidentially inform you of your legal rights and options at no cost or obligation to you an help you evaulate whether to pursue a Digitek lawsuit for injuries you have suffered from Digitek side effects. Contact Us Today.