Consumer Alert: Digitek Heart Failure Medications Recalled - A Serious Risk of Injury or Death to the Patient
May 21, 2008
On April 25, 2008 Actavis Totowa LLC (formerly known as Amide Pharmaceutical, Inc.) announced the Class I nationwide recall of all strengths of oral Digitek tablets, which is a brand name for digoxin tablets, USP 0.125 mg and 0.25 mg. The products are manufactured by Actavis Totawa LLC, a division of the international generic pharmaceutical company Actavis Group, and distributed by Mylan Pharmaceuticals, Inc. under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.
The Reason Behind the Nationwide Recall:
Digitek is used to treat heart failure and abnormal heart rhythms. Unfortunately, all lots of the drug have been voluntarily recalled because tablets may be double the appropriate thickness and thus tablets may contain twice the approved level of the active ingredient. The existence of double-strength tablets poses a risk of toxicity in patients with renal failure and those who are on dialysis.
How the Recalled Medications Can Injure Patients:
Too high a dosage of Digitek can cause Digitalis toxicity, which can lead to nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia and even death. The recall was initiated after several reports of injuries and illnesses have been received.
Attorneys at Robins, Kaplan, Miller & Ciresi L.L.P. are currently investigating claims related to Digitek. If you or someone you know has been injured or killed following use of Digitek and you wish to consult with a lawyer, please call Kate Jaycox at 1-800-553-9910 or 612-349-8500 or e-mail us by clicking on this link: contact us.
 Press Releases, Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as a precaution, dated April 25, 2008, available at http://www.actavis.us/en/media+center/newsroom/articles/digitek+recall.htm or at Recall - - Firm Press Release, http://www.fda.gov/oc/po/firmrecalls/actavis04_08.html.
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