Ebek voluntarily recalls Liviro3.

Ebek announced Jan. 19 that it is conducting a voluntary nationwide recall of the company's supplement product sold under the name Liviro3. The company has been informed 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, the agency stated in a release.

FDA advised that this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels.

According to FDA, consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. 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.

No illnesses have been reported to the Company to date in connection with this product.

The public is encouraged to submit a report of any serious adverse events that occur with the use of Liviro3 to FDA's MedWatch Adverse Event Reporting program online www.fda.gov/MedWatch/report.htm ], by phone [800-FDA-1088], or by returning the post-age-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 [800-FDA-0178].