The Food and Drug Administration (FDA) released the following information:
Ebek, Inc. Issues Voluntary Nationwide Recall of Liviro3, a Product Marketed as a Dietary Supplement
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 online [at www.fda.gov/MedWatch/report.htm ], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].
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 email@example.com to receive further instructions for returning the product or with any questions.
Type of Recall:
Class I - This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.