| U.S. Food and Drug Administration |
FDA Press Release, January 29, 2007
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Counterfeit Liviro3 Discovered After Voluntary Recall Announcement
FOR IMMEDIATE RELEASE -- Los Angeles, CA -- January 29, 2007
-- Ebek, Inc., 3921 Wilshire Boulevard, Suite 307, Los Angeles, Ca 90010. Ebek,
Inc. was informed by representatives of the Food and Drug Administration (FDA)
that lab analysis by FDA of Liviro3 samples found the product contains
tadalafil, an FDA-approved drug used to treat erectile dysfunction (ED), making
Liviro3 an unapproved drug. On January 19, 2007,
Ebek announced it was conducting a voluntary nationwide recall of Liviro3.
During the voluntary recall process, Ebek discovered counterfeit Liviro3 on the
market. Both Ebek's Liviro3 and the counterfeit "Liviro3" are undergoing
renewed, independent testing. Please see diagram below to compare Ebek Liviro3 and counterfeit product.
Consumers who have either the genuine or counterfeit Liviro3 product in their
possession should stop using it immediately and contact their physician if they
have experienced any problem that may be related to taking either of these
products. The public is encouraged to submit a report of any serious adverse
events that occur with the use of Ebek Liviro3 or counterfeit Liviro3 to the
FDA's MedWatch Adverse Event Reporting program by phone 1-800-FDA-1088.
Ebek has taken this action because it is committed to providing accurate
information about its products and because of concern for the health and safety
of consumers.
Consumers should return any unused genuine Ebek Liviro3, for a full refund of
the full price or price for the unused portion, to the retail location where it
was purchased or to Ebek directly at (213) 480-0316 or by email at recall@liviro.com to receive further
instructions for returning the product or with any questions. Consumers
are requested to send any unused counterfeit product to Ebek, pending
further instruction. Ebek will not issue a refund for counterfeit product but
will appreciate receiving the counterfeit product for further investigation.
Below is a diagram explaining how a consumer may tell if they have genuine vs. counterfeit Liviro3:
|
Genuine Ebek Liviro3 |
Counterfeit Product |
|
Raised "Liviro3" lettering (front and back) |
NO raised lettering (front or back) |
|
Gold embossed "3™" (front and back) |
NO gold (front or back) |
|
Manufactured by Ebek™ Laboratory (front, lower left corner) |
A brand of Natural V (front, lower left corner) |
|
1-888-470-EBEK (3235) (back, lower right corner) |
213-480-0200 (back, lower right corner) |
This advisory was prepared by the FDA Office of Public Affairs.