Recall notice from FDA on Digitek (digoxin tablets)
- 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
Mon, 28 Apr 2008 09:50:00 -0500
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
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
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.