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FDA Press Release, January 19, 2007
Recall -- Firm Press Release
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and other notices of recalls and market withdrawals from the firms involved as a
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Ebek, Inc. Issues Voluntary Nationwide Recall of Liviro3, a Product Marketed as a Dietary Supplement
FOR IMMEDIATE RELEASE -- Los Angeles, CA -- January 19, 2007
-- Ebek, Inc., 3921 Wilshire Boulevard, Suite 307, Los Angeles, Ca 90010,
announced today that it is conducting a voluntary nationwide recall of the
Company's supplement product sold under the name Liviro3. The Company has been
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. FDA advised that this poses a threat to consumers because
tadalafil may interact with nitrates found in some prescription drugs (such as
nitroglycerin) and may lower blood pressure to dangerous levels. According to
the FDA, consumers with diabetes, high blood pressure, high cholesterol, or
heart disease often take nitrates. FDA advises that ED is a common problem in
men with these conditions, and they may seek products to enhance sexual
performance. FDA advises that tadalafil, may cause side effects, such as
headaches and flushing.
The recalled Liviro3 is sold in 10-tablet boxes or 20-tablet plastic bottles.
The product label warns consumers with high blood pressure not to ingest the
product but does not state it contains tadalafil.
Consumers who have Liviro3 in their possession should stop using it
immediately and contact their physician if they experienced any problem that may
be related to taking this product. The public is encouraged to submit a report
of any serious adverse events that occur with the use of Liviro3 to the FDA's
MedWatch Adverse Event Reporting program by phone at 1-800-FDA-1088.
Ebek has taken this voluntary action because it is committed to providing
accurate information about its products and because of concern for the health
and safety of consumers. Ebek is working with the FDA in the recall process. It
sincerely regrets any inconvenience to customers.
No illnesses have been reported to the Company to date in connection with
this product.
Consumers should return any unused Liviro3, for a refund of the full purchase
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.
Follow-up press release
This advisory was prepared by the FDA Office of Public Affairs.