WASHINGTON, DC (FDA)--INZ Distributors Inc./Magic Power Coffee Inc., of Brooklyn, NY announced today that it is conducting a voluntary nationwide recall of the dietary supplement product sold under the name, Magic Power Coffee.
The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis of one lot of the product by the FDA found that the product contains undeclared hydroxythiohomosildenafil, similar in structure to Sildenafil, an FDA-approved drug used for the treatment of male Erectile Dysfunction (ED), making Magic Power Coffee an unapproved drug. The hydroxythiohomosildenafil drug ingredient is not listed on the product label.
Hydroxythiohomosildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
Magic Power Coffee is distributed nationwide on Internet sites and online auctions by multiple independent distributors participating in an online multi-level marketing program. It is sold in a 2-serving box with UPC 718122686872 and a 12-serving carton containing six 2-serving boxes with UPC 718122686773. All production dates up until 05/08/2010 are being recalled.
To date, no illnesses have been reported to the company or the FDA in connection with this 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.
Consumers and health care professionals should report adverse events that may be related to the use of this product to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm1, by phone at 1-800-FDA-1088 or by returning the postage-paid FDA form 3500 which may be downloaded from www.fda.gov/MedWatch/getforms.htm2 by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax to 1-800-FDA-0178.
Consumers should return any unused product to the place of purchase for full refund or contact INZ Distributors Inc./Magic Power Coffee Inc. at (718) 313-1579, Monday - Friday, 10 am to 6 pm EDT, for further instructions.
Information Provided By: U.S. Food and Drug Administration