Cosmos Trading Recalls Rhino Max

Updated March 19, 2007

Donna Young

BETHESDA, MD, 19 March 2007—FDA on Friday alerted consumers and health care professionals about a voluntary nationwide recall of Rhino Max, a dietary supplement product marketed by Los Angeles-based Cosmos Trading.

According to a press release posted on FDA's website, Rhino Max's labeling fails to inform consumers and practitioners that the product contains aminotadalafil, which is an analogue of tadalafil, the active ingredient in Eli Lilly's erectile dysfunction drug Cialis.

FDA Issues Alert on V.Max

FDA on Monday afternoon issued a MedWatch alert notifying the public about a voluntary recall of V.Max, a dietary supplement marketed by California-based Barodon SF.

According to FDA, V.Max's labeling fails to inform consumers and practitioners that the product contains aminotadalafil, which is an analogue of tadalafil, the active ingredient in Eli Lilly's erectile dysfunction drug Cialis.

Consumers were told to stop using V.Max, which is sold in packages of 15 capsules, and to contact their health care provider with any concerns about the product.

Bardon SF advised consumers to contact the firm at (213) 381-8272 for instructions about how to return the product for a full refund.

An FDA analysis of the product revealed the problem. The agency in January notified the public of a similar problem with Ebek's Liviro3, which was found to contain tadalafil. Counterfeit versions of Liviro3 were also discovered on the market.

In July 2006, regulators warned the public about dietary supplements that contained sildenafil, the active ingredient in Pfizer's Viagra, and analogues of either sildenafil or vardenafil, the active ingredient in Levitra, marketed in the United States by GlaxoSmithKline and Schering-Plough.

FDA warned that aminotadalafil may interact with nitrate products, causing a person's blood pressure to plummet to dangerous levels. The product's labeling fails to warn consumers with high blood pressure not to take the product, according to the company's press release. Aminotadalafil may cause other adverse events such as headaches and flushing.

Although makers of dietary supplements do not have to seek FDA approval to market their products, manufacturers must ensure that product labeling is truthful and not misleading. Because Rhino Max contains aminotadalafil, Cosmos Trading's product is an unapproved drug, according to regulators.

Consumers who purchased Rhino Max, which is sold in boxes of 5 or 15 tablets, were advised to stop using the product and contact their health care provider.

Cosmos Trading encouraged consumers and health care practitioners to report any serious adverse events related to the use of Rhino Max to the FDA's MedWatch program at www.fda.gov/MedWatch/report.htm or by calling (800) 332-1088.

No illnesses linked to Rhino Max have been reported to Cosmos Trading, the company said in its statement, adding that the firm is working with FDA in the recall process.

The company advised consumers to return any unused portions of Rhino Max to the retail location where the product was purchased or to contact Cosmos Trading at (213) 598-6699 to receive instructions for returning the product to the firm.