DIGITEK® TABLETS RECALL:
Recalled heart medication tablets pose a serious risk of illness or injury due to overdose, or digitalis toxicity.
On April 28, 2008, the U.S. Food and Drug Administration posted a nationwide recall by Actavis Totowa LLC of all Digitek® tablets — generically known as digoxin. The tablets were recalled after it was discovered that a number of lots had been defectively manufactured with double the approved level of active ingredient.
In August 2008, all Digitek lawsuits were consolidated into a multi-district litigation (MDL) after a growing number of lawsuits were filed by individuals against Actavis and its distributors for the defective product.
On November 5, 2008, KCR personal injury attorney C. Brooks Cutter was appointed to the plaintiffs’ steering committee for the Digitek multi-district litigation.
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Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, initiated a Class I nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek” label and by UDL Laboratories, Inc. under a "UDL” label.
All lots were recalled due to defective manufacturing which resulted in tablets with double the appropriate thickness and twice the approved level of active ingredient than appropriate.
Digitek, which is used as a heart medication, has been linked to hundreds of serious and fatal injuries in people who received the defective, double-strength tablets and suffered from digitalis toxicity.
Read the FDA Digitek recall
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Digitek® tablets are taken orally and are used to treat congestive heart failure and abnormal heart rhythms. Digitek is generically known as digoxin, which is derived from the leaves of the digitalis plant.
Digoxin is sold by several other companies under different brand names.
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The double-strength Digitek tablets pose a serious risk of illness or injury due to overdose, or digitalis toxicity. Digitalis toxicity can cause:
- Low blood pressure
- Cardiac instability
- Bradycardia, a slower than normal heart rate
Patients with kidney dysfunction have an especially high risk for digitalis toxicity.
If you or a loved one has taken Digitek tablets and has suffered injury, illness or any of the symptoms of digitalis toxicity, contact your doctor immediately. You are also encouraged to report any adverse reactions to the FDA’s MedWatch Program:
- By phone at 1-800-FDA-1088
- By Fax at 1-800-FDA-0178
- By mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
- Online at MedWatch website at www.fda.gov/medwatch
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Contact an Experienced Personal Injury Attorney
KCR personal injury attorneys have handled thousands of cases involving defective and dangerous drugs such as Digitek. KCR currently represents and has litigated and settled numerous nationwide cases involving dangerous drugs and medical devices and products such as:
We have the specific knowledge and expertise to help our injured clients obtain fair compensation in these complex cases.
If a loved one has died from adverse reactions of the defective, double-strength Digitek tablets, you may be entitled to wrongful death compensation or compensation to the estate.
If you or a loved one has taken Digitek tablets and suffered injury, illness or even death, please fill out and submit the contact form on this page for a free case evaluation or call us toll-free at (888) 285-3333 to talk with a wrongful death or personal injury attorney.
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