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Recall notice from FDA on Digitek (digoxin tablets)

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  • Carol
    One of our members, Marcia, sent me a recall notice regarding Digitek (digoxin tablets), so thought it might be important if anyone here uses this medication.
    Message 1 of 1 , Apr 29, 2008
      One of our members, Marcia, sent me a recall notice regarding
      Digitek (digoxin tablets), so thought it might be important if
      anyone here uses this medication. Following is the FDA memo.

      Carol and Snowball and the gang


      From: fda@...
      Mon, 28 Apr 2008 09:50:00 -0500

      Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.)
      recalls all lots of Bertek and UDL Laboratories DigitekĀ® (digoxin
      tablets, USP) as precaution.

      Contact: Stericycle customer service, 1-888-276-6166

      FOR IMMEDIATE RELEASE -- 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 DigitekĀ® (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 voluntary all lot recall 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 it appropriate.

      DigitekĀ® 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. Digitalis toxicity can
      cause nausea, vomiting, dizziness, low blood pressure, cardiac
      instability and bradycardia. Death can also result from excessive
      Digitalis intake. Several reports of illnesses and injuries have
      been received.

      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.

      Any customer inquiries related to this action should be addressed to
      Stericycle customer service at 1-888-276-6166 with representatives
      available Monday through Friday, 8 am to 5 pm EST. Additional
      information about the voluntary recall can also be found at

      Retailers who have this product are urged to return the product to
      their place of purchase. If consumers have medical questions, they
      should contact their health care providers.

      This recall is being conducted with the knowledge of the Food and
      Drug Administration.

      Any adverse reactions experienced with the use of this product,
      and/or quality problems should also be reported 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, or on the MedWatch website at www.fda.gov/medwatch.
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