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On April 25, 2008, the Food and Drug Administration (FDA) issued a Class I Digitek® recall due to the possibility that certain tablets were found to contain double doses of the drug. Class I FDA recalls indicate that a medication has significant risk of causing severe injury or death.
Generically known as digoxin, Digitek® is a medication prescribed to treat arrhythmias and congestive heart failure.
While Digitek® is currently marketed by GlaxoSmithKline, Actavis Totowa owns the trademark "Digitek®." The Digitek® drug is also distributed by Mylan Pharmaceuticals (under the name Bertek).
While Digitek® drug side effects can affect any patient, those with the highest risk include patients who:
• have a history of heart block, heart attack, kidney disease and/or thyroid disorders
• take high doses of Digitek®
• overdose on Digitek® (which occurred widely following the release of the double-dosed tablets)
The most serious, potentially fatal side effects associated with Digitek® overdoses can include:
• acute psychosis
• depression
• heart block
• hallucinations and/or delirium
• irregular, faster or slower heartbeat
• severe allergic reaction (characterized by breathing problems, facial or tongue swelling, hives, etc.)
Patients taking the correctly prescribed Digitek® doses may also be at risk of developing:
• abdominal pain
• anxiety
• blurry vision
• confusion
• depression
• diarrhea
• fatigue
• intestinal hemorrhage (bleeding) or necrosis (death)
For the specific lot numbers of the recalled Digitek® tablets, see the table below:
Recalled Digoxin Tablets, USP
Dosage Lot Number Expiration Date
125 mcg (0.125 mg) 7A666 7/08
7F048 10/08
7D352 12/08
7P862 3/09
8C515 9/09
6S406 5/08
7J541 1/09
7M709 3/09
7P965 4/09
8B371 8/09
250 mcg (0.25 mg) 6S379 5/08
7C971 9/08
7J535 1/09
7V200 6/09
7P963 4/09
8A332 7/09
Digitek® patients who have taken one of the above recalled tablets (or families of deceased Digitek® patients who have taken recalled tablets) should set up an initial consultation with a Digitek® recall lawyer.
During this meeting, prospective plaintiffs can:
• Find out if they have a case against GlaxoSmithKline, Actavis Totowa or Mylan Pharmaceuticals
• Get a better understanding of the process of starting and winning a Digitek® recall lawsuit
• Get advice about whether starting an individual case or joining an already-progressing Digitek® recall lawsuit is best for their needs and circumstances
To encourage affected individuals to seek out the compensation they deserve, Digitek® attorneys will offer these consultations for free and will delay payment for their services until a settlement in recovered.
By following through with a Digitek® lawsuit, plaintiffs can win compensation for their:
• burial and funeral costs
• hospital bills
• lost wages
• ongoing treatment costs
• pain and suffering
• permanent inability to work
Have you or a loved one been injured after taking Digitek®? If so, contact us to speak with an experienced Digitek® attorney who specializes in drug recall litigation & lawsuits. Let us help you win the compensation you need and deserve.