More proof of a tootless FDA, here is information of a so-called
"voluntary"
recall of Digitek pills which may be DOUBLE strength. The recall was
issued
in April and the letters went out marked "May", no date. Despite warnings
not to take the pills, the local Wal-Mart has no replacements in stock
today, maybe tomorrow, except fully-branded ones for which you pay full
price (not $4). Anyway, here is the voluntary announcement with notation
that the company will only answer calls during NORMAL business hours...NO
WEEKENDS please. Don't disturbe them. They are busy:
Morristown, NJ, 25 April, 2008 - Actavis Totowa LLC, a United States
manufacturing division of the international generic pharmaceutical company
Actavis Group, is initiating a Class 1 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 is
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 re****ts of
illness
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 re****ted 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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I bet they were made in India.
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