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The following information has been received by our office from the U.S. Food and Drug Administration (FDA).
Young Sam Jung
FOR IMMEDIATE RELEASE: - Los Angeles, CA – March 16, 2007 – Cosmos Trading, Inc., 1543 Olympic Blvd, Suite# 419 Los Angeles, CA 90015, announced today that it is conducting a voluntary nationwide recall of the Company’s supplement product sold under the name Rhino Max (Rhino V Max). The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Rhino Max (Rhino V Max) samples found the product contains Aminotadalafil. Aminotadalafil is an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED), making Rhino Max (Rhino V Max) an unapproved drug. FDA advised that 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. FDA advises that ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. FDA advises that Aminotadalafil, may cause side effects, such as headaches and flushing.
The recalled Rhino Max (Rhino V Max) is sold in 5-tablet boxes or 15-tablet boxes. The product label does not warn consumers with high blood pressure not to ingest the product. Also, it does not state it contains Aminotadalafil.
Consumers who have Rhino Max (Rhino V Max) 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. The public is encouraged to submit a report of any serious adverse events that occur with the use of Rhino Max (Rhino V Max) to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm ], by phone [1-800-FDA-1088], or by returning the postage-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 [1-800-FDA-0178].
Cosmos Trading has taken this voluntary action because it is committed to providing accurate information about its products and because of concern for the health and safety of consumers. Cosmos Trading is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.
No illnesses have been reported to the Company to date in connection with this product.
Consumers should return any unused Aminotadalafil, for a refund of the full purchase price or price for the unused portion, to the retail location where it was purchased or to Cosmos Trading directly at (213) 598-6699 to receive further instructions for returning the product or with any questions.
This product may have been distributed in your area. Please spot-check stores for effectiveness of the recall. If you have any questions, please feel free to contact this office at 317/233-7360.