Digitek Tablets Recalled as They May Contain a Dangerous Double Dose of the Active Ingredient

Actavis Totowa LLC has issued a Class 1 nationwide recall of all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP, all strengths) for oral use because the recalled pills may contain two times the proper dosage of the drug’s active ingredient, digoxin.

Double-strength tablets pose a risk of digitalis toxicity, which can cause nausea, vomiting, dizziness, abnormal vision, low blood pressure, cardiac instability, irregular or slow heart rate, and death, according to the Recall Notice.

"Tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than is appropriate," states an Actavis Totowa news release posted on the FDA's web site.

This recall, unfortunately, comes too late for the patients and families whose loved ones unknowingly were overdosed by ingesting the potentially deadly tablets. Heart patients or their loved ones have already reported illnesses and injuries to the FDA and Actavis Totowa.

On April 25, 2008, Actavis Totowa sent out the voluntary recall of its heart treatment drug, Digitek, which is a prescription oral pill used to treat heart failure and abnormal heart rhythms by making the heart beat more efficiently.

The company also said that these high levels of digoxin pose a risk of digitalis toxicity in patients with renal failure who, unlike other patients, are unable to discharge digitalis from their bodies.

Digitek is manufactured by Actavis Totowa LLC, a United States manufacturing division of the Iceland-based generic pharmaceutical company Actavis Group. It is distributed by Mylan Pharmaceuticals Inc. and sold under the label "Bertek." It is also distributed by UDL Laboratories Inc. and sold under the label "UDL."


Contact Baum, Hedlund, Aristei & Goldman
for a free consultation if you or a loved one have been injured by Digitek.
The firm is representing many patients who are suffering injuries
since taking the defective Digitek.

All lots of Digitek have been recalled.

To report side effects to the FDA, call the FDA’s hotline at 800-FDA-1088 or visit the FDA's MedWatch web site.  

To get legal representation for a personal injury or wrongful death claim, contact us today for a free initial consultation.