FDA medwatch:
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Digitek (digoxin tablets, USP)
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Audience: Cardiologists, family physicians, pharmacists, other healthcare professionals, patients
[Posted
04/28/2008] Actavis Totowa LLC notified healthcare professionals of a
Class I nationwide recall of all strengths of Digitek, a drug used to
treat heart failure and abnormal heart rhythms. The products are
distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and
by UDL Laboratories, Inc. under a “UDL” label. The product is being
recalled due to the possibility that tablets with double the
appropriate thickness may contain twice the approved level of active
ingredient. The existence of double strength tablets poses a risk of
digitalis toxicity in patents with renal failure. Digitalis toxicity
can cause nausea, vomiting, dizziness, low blood pressure, cardiac
instability and bradycardia. Several reports of illnesses and injuries
have been reported. Patients should contact their healthcare
professional with questions.
Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.)
recalls all lots of Bertek and UDL Laboratories Digitek® (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 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 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.
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. 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 www.actavis.us.
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.
