Recall of Digitek (Digoxin Tablets)

Brenda Fulmer
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Posted by Brenda FulmerMay 08, 2008 3:39 PM

U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration along with Actavis Totowa (formerly Amide Pharmaceutical) recently announced the recall of Digitek (digoxin) tablets that are distributed in the United States by Mylan Pharmaceuticals (under a "Bertek" label) and UDL Laboratories.  The recall was initiated due to manufacturing defects in the Digitek tablets that caused the pills to be double the appropriate thickness and, as a result, double the expected strength.  Digitek (digoxin tablets) are powerful drugs used to treat heart rhythm abnormalities.  Patient who receive an overdose of this medication could suffer life-threatening toxicity, especially in patients with pre-existing kidney disease or renal failure.  Symptoms of Digitek toxicity include:  nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia (abnormal heart rhythm).  According to the FDA, there have been several reports of illnesses and injuries reported in connection with the defective manufacture of the Digitek tablets. 

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Rhonda Klegerman
Posted by Rhonda Klegerman
May 10, 2008 7:38 PM

I was recently hospitalized two weeks ago for atrial fibriliation that lasted for over a week. I happened to have an implanted defibrilator and they did a cardio conversion on me after a week.

I have been taking digoxin (Digitek) for some time now. When I was in the Emergency Room they did blood tests and my digoxin level was 2.4. After that the levels came down (I was taking their own digoxin in the hospital), but I have been home for a week and I have been taking the Digoxin (bertek)prescription ( I take one every other day. I took one this morning and then I received two letters in the mail that were dated May 1st and I did not get them until today, May 10th.I have chronic kidney disease. I have been suffering from loss of appetite, weight loss, nausea, a lot of weakness and am constantly sleeping. I am almost positive now that all my symptoms are stemming from this digoxin. I am going to the doctor on Monday and will have him do a blood test on digoxin and everything else. Who can I sue if in deed I have permanent damage from this medical nightmare? This is the United States of America, you think we were in some impoverished nation that didnt know any better and can't check their own food, medicines, dog and cat good,and toys for poison. After all these deaths and recalls of everything under the sun,I am sick and tired and don't feel one bit safe in this country!!!!!!

Jenny Beaver
Posted by Jenny Beaver
May 13, 2008 3:43 PM

Dear Ms. Klegerman,
If you are interesting in speaking with us in further detail regarding use of Digitek, please contact us at (813) 222-0977 or (800) 840-0977. You may also visit us on the web at: More ... Thank you for your comments.

jeremy knaebel
Posted by jeremy knaebel
May 22, 2008 4:24 PM

I was just told a story of someone who was on this for a couple of months and died from heart failure. How can you determine if the pills that he was taking were the ones with the defective dosage? His medication could have been the right strenghth. Is there any way to find out?

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