Morristown, NJ -- April 25, 2008 -- Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating 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.


The Class I Recall of all lots is due to the possibility that 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.


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Digitek® is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure.


  OVERDOSE SYMPTOMS:

  •   Death
  •   Low blood pressure
  •   Cardiac instability
  •   Bradycardia
  RECALLED MEDICATION LIST:

  •   Digitek
  •   Digoxin
  •   Lanoxin
  •   Cardoxin
  •   Lanoxicaps
  MANUFACTURERS:

*Actavis manufactures the products for Mylan and the products are distributed by Mylan and UDL under the Bertek and UDL labels. Bertek and UDL are affiliates of Mylan.



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