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The following information has been received by our office from the U.S. Food and Drug Administration (FDA).
Kim Y. Oh
FOR IMMEDIATE RELEASE: Los Angeles, CA March 15, 2007- Barodon SF, 2823 W. 8TH St, Los Angeles, CA 90005, announced today that it is conducting a voluntary nationwide recall of the company’s supplement product sold under the name V.MAX. Barodon SF is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of V.MAX samples found the product contains aminotadalafil. Aminotadalafil is an analog of Tadalafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). This poses a threat to consumers because aminotadalafil 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. According to the FDA, ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. Additionally, FDA advises that aminotadalafil may cause side effects, such as headaches and flushing.
V.MAX is sold nationwide and in the past has also been exported to South Korea and Japan. V.MAX is packaged with an outer box containing three smaller inner boxes each containing five capsules making it a total of 15 capsules per unit.
Consumers who have V.MAX in their possession should stop use immediately. In the event of any adverse side effects due to its consumption, consumers should contact a physician right away. Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
The company advises that any unused portion be returned to Barodon SF, Inc. for a full purchase price refund by calling (213) 381-8272 for instructions on the return and refund process.
No illnesses have been reported to the company to date in connection with this product.
Barodon SF, Inc.apologizes for any inconvenience and expresses its concerns for the health of consumers by conducting a voluntary recall action. Barodon SF, Inc. promises to ensure quality and integrity of all its products and the company is working closely with the FDA in the recall process to prevent further issues regarding V.MAX.
Please spot check these additional sources of peanut butter product and ensure they are not being used. Please see the attached Q & A document that addresses many of the questions consumers have been asking as if will be of help to you.