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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Counterfeit Liviro3 Discovered After Voluntary Recall Announcement

 

Contact:
Yu Kim
(213) 480-0316

 

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 and pictures 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 online [at www.fda.gov/Safety/MedWatch/HowToReport/default.htm], by phone [1-800-FDA-1088] or by returning the postage paid FDA form 3500 [which may be downloaded from www.fda.gov/Safety/MedWatch/DownloadForms/default.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

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 Liviro3Counterfeit 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)

 

Pictures Comparing Ebek Liviro3 and Counterfeit Product

 

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