News Flash

Liviro3 Dietary Supplement Recalled

Liviro3, a dietary supplement produced by Ebek, Inc. has been recalled by the Food and Drug Administration (FDA) and the manufacturer.

Consumers who purchased Liviro3 10-tablet boxes or 20-tablet plastic bottles should stop using the supplement immediately and contact a physician if they experience any side effects – such as headaches and flushing.

The voluntary recall is underway because the product contains tadalafil, a drug used to treat erectile dysfunction. Liviro3 is not approved by the FDA to contain this drug or for this condition. Risks are greatest to consumers already taking prescriptions for diabetes, high blood pressure, high cholesterol or heart disease because those prescriptions often contain nitrates that may interact with tadalafil and lower blood pressure to dangerous levels.

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:  www.fda.gov/MedWatch/report.htm
• by phone: 1-800-FDA-1088
• by mail or fax: Return FDA Form 3500 which may be downloaded from www.fda.gov/MedWatch/getforms.htm.

Additional information, including health information and directions for receiving a full refund, is available on the FDA web site:

• http://www.fda.gov/oc/po/firmrecalls/ebek01_07.html