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.[1]  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.[2]

The Reason Behind the Nationwide Recall:

Digitek is used to treat heart failure and abnormal heart rhythms.[3]  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.[4]  The existence of double-strength tablets poses a risk of toxicity in patients with renal failure and those who are on dialysis.[5] 

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.[6]  The recall was initiated after several reports of injuries and illnesses have been received.[7] 

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

[1] Press Releases, Digitek Recall - Customer Support and Frequently Asked Questions, dated May 9, 2008
[2] 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. 
[3] Id. 
[4] Id. 
[5] Id. 
[6] Id. 
[7] Id.
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