Class I Recall Issued for Digitek Tablets

Scott Kappes
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Posted by Scott KappesApril 28, 2008 6:36 PM
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Today the Actavis Totowa LLC in conjunction with the FDA issued a Class I recall of all Digitek tablets. Digitek is used to treat abnormal heart rhythms and heart failure; however, the company has learned that some pills may be twice as thick and contain double the approved level of the active ingredient. Taking these double strength tablets could result in an elevated risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause low blood pressure, dizziness, cardiac instability, nausea, vomiting, and bradycardia (a heart rate below 60 bpm).The tablets are distributed by Mylan Pharmaceuticals Inc, under a “Bertek “label, and also by UDL Labratories Inc, under “UDL” a label.

 


Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions. Retailers are encouraged to remove all recalled products from their shelves and return to their place of purchase. Additiional information can be found at www.actavis.us.

12 Comments

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Linda Porter
Posted by Linda Porter
April 29, 2008 3:56 PM

My Mother has become very ill in the past few weeks. She is 78 and is taking Digitek. She is so ill that she has seen a neurologist and is having a cat scan done tomorrow. The pharmacist just called to inform us about the Digiteck recall and the problems associated with it. Her symptoms include severe fatigue, to the point she hardly gets out of bed. She slurs her words, she talks to and sees people who aren't there, and she has suddenly started to experience memory loss.

tina shively
Posted by tina shively
May 01, 2008 8:25 AM

how do I know which ones this effects? I have two people taking this, please let me know asap

Cathy Hare
Posted by Cathy Hare
May 01, 2008 12:39 PM

Oh my gosh!!!! This explains EVERYTHING my mother, who is 81, is going through right now. They have increased her medicine 3 times for narcolepsy because she can't stay awake! We thought she was going to pass on Saturday. She was doing well until a couple weeks ago. A week ago her Assisted Living place put her on oxygen because she literally fell asleep all the time...even during meals. She couldn't stay awake for 15 seconds at a time and I'm NOT exagerating. She had all the signs of congestive heart failure. They took her off of it and today when I was with her she stayed awake the entire time I was there...4 1/2 hours. I'm beginning to think drug companies kill more people than they save!!!!! I'm furious!!!!!!!!!!!!!!!!!!!

Peggy Lander
Posted by Peggy Lander
May 01, 2008 1:21 PM

Mom was doing fine. She is living in assisted living rather than a nursing home because she can pretty much take care of herself. Within the last 2 weeks she went down hill FAST. My mother received Last Rights from our priest because she was in such bad shape. She could not stay awake, she was too weak to even walk and had to be in a wheel chair, needed oxygen or her levels went below 90 and needed help to eat. She is off of the meds now and I hope she returns to her old self.

Scott Kappes
Posted by Scott Kappes
May 01, 2008 1:28 PM

Tina, I guess I don't really understand your question. The recall applies all Digitek tablets, and patients with renal failure are at an elevated risk. I would advise you to contact a physician who may be able to better assist you with the particulars of your case.

Jerome Lambe
Posted by Jerome Lambe
May 01, 2008 7:48 PM

I have been taking Digiteck 250 mcg once a day for over a year now along with other medications for A Fib. The past 6 months I have gotten increasingly tired with a very low level of energy if any at all, all I want to do is sit in a chair and watch TV. I have enrolled in a Cardio Fitness Center to increase my activity but most days I am too weak to even go.

Jerome Lambe
Posted by Jerome Lambe
May 01, 2008 7:50 PM

I have been taking Digiteck 250mcg once a day for over a year, and have the same tired weak no energy feeling that the others have stated. I am talking to my doctor tomorrow about this. Thank God for my CVS drug store, they are the ones that told me about this recall and replaced the pills. Another thing to worry about.

H Reed
Posted by H Reed
May 01, 2008 11:25 PM

I was taking .50mg of digitek during mar. & apr. of 2008. I had all the same side affect's like nausea,diarrhea,shortness of breath,memory loss,fatigue and green vision. I'm now taking .25mg of Lanoxin and my symptom's cleared up.

GEORGE WINGHAM
Posted by GEORGE WINGHAM
May 06, 2008 11:38 AM

WAL MART’s data base disclosed our daughter was taking Digitek last summer.

WAL MART's data base disclosed our daughter was taking Digitek last summer.

Our daughter's DEATH CERTIFICATE shows CARDIAC ARREST as primary cause. Examination of medical records disclosed very low blood pressure. Combined with extremely low Ejection Fractions (EF) during this period and other symptoms, we will investigate this matter to the fullest extent. Digitek might be a KILLER DRUG.

We received the WAL MART notice less than two weeks after the actual FDA Class 1 notice. It is good WAL MART had the presence of mind to act concerning this recall, unlike the competition (Walgreen). Or we would have likely never known.

THANK YOU WAL MART.

We will report findings on this blog in the future in case our situation can help someone else.

One more thing. China, Europe and other so-called "emerging nations" perpetually send poisonous stuff to our country. Seems like I read defective Digitek was made in ICELAND. Rather than blame Dubya and the FDA, seems like it would be better to hold manufacturers accountable and responsible for their actions. JAIL TIME FOR CEOs.

Tamara Garland
Posted by Tamara Garland
May 12, 2008 3:43 PM

My dad was taking this same drug last year. When this drug became recalled, it was too late. He died...I am going to investigate to the fullest. If anyone knows a lawyer that will except this case please contact me. At Tgarland3@hotmail.com

Thanks

Laura
Posted by Laura
May 19, 2008 2:49 PM

Last summer, my sister began to have symptoms like those caused by digitalis toxicity. She was hospitalized twice. The second time, she was diagnosed with digitalis toxicity. She died three weeks later of heart arrythmias. Her doctors were shocked.

She was taking Digitek.

Ann Piscarik
Posted by Ann Piscarik
May 20, 2008 11:43 AM

My husband was taking Digoxin made by Bertek. I have a receipt for his prescription last June for 45 tablets. He had a spell the end of June with side effects mentioned. He was hospitalized for a week at a hospital an hour or more from home. He passed away July 31. As far as I know, he was still taking this medication.

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