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.
America True Man Health Incorporated's Voluntary Recall of its True Man's Sexual Energy Nutriment Men's Formula, a Product Marketed as a Dietary Supplement to Enhance Male Sexual Energy has been expanded to include its Energy Max, Dietary Supplement
America True Man Health Incorporated
FOR IMMEDIATE RELEASE -- November 16, 2007 - - American True Man Health Incorporated announced that it is expanding it's voluntary recall of the Company's dietary supplement product sold under the name and identified as True Man's Sexual Energy Nutriment Men's Formula with the expiration date up to and including December 2010 to also include the dietary supplement product sold under the name and identified as Energy Max, Energy Supplement Men's Formula (the products) with the expiration date up to and including December 2010. Finished products from several lots of these products were tested and were found to contain an analog of an ingredient in an FDA-approved drug. The analog resembles the active pharmaceutical ingredients in Tadalafil, Vardenafil, and Sildenefil, FDA-approved drugs used to treat erectile dysfunction (ED). Consequently, the products may possess a similar pharmacological and adverse event profile, posing a threat to consumers because of interaction with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, who may seek products to enhance sexual performance. Additionally, the product may cause side effects, such as headaches and flushing.
The recall is being done notwithstanding that the Company is unaware of any adverse effects having been reported or associated with the product.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
The Company is advising consumers to return any unused product, for a full refund of the purchase price, to the retail location from which it was purchased, or to the Company directly if it was purchased from the Company. Consumers can call the Company at 1-888-478-1888 for instructions for returning the product.
Any adverse events that may be associated with the use of this product and/or quality problems should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch website at www.fda.gov/medwatch.
The Company is taking this voluntary action because it is concerned with individual health. The Company is working with the FDA in the recall process and is committed to the quality and integrity of its products. The Company has switched suppliers and is testing all shipments received before resale to customers and regrets any inconvenience.
FDA Press Release (Nov. 2, 2007)