Solo Slim and Revivexxx Recalls Issued After FDA Identifies Undeclared Drugs

The weight loss product Solo Slim and the male enhancement product Revivexxx, both sold as dietary supplements, have been recalled after the FDA discovered that they contain undeclared drug ingredients.  

The Solo Slim recall and Revivexxx recall were announced on August 6 by FDA after testing found drugs that should be declared on the packaging, which disqualifies them from being unregulated dietary supplements. Both products were distributed by EZVille, Ltd., of Ronkonkoma, New York. There have been no reported illnesses or injuries associated with the recalled products.

An FDA lab analysis found that Revivexxx contained the drug Tadalafil, which is used to treat male Erectile Dysfunction (ED). Tadalafil, sold under the brand name Cialis, was approved to treat ED by FDA in November, 2003. Side effects can include sudden hearing loss, vision impairment, headache, indigestion, and muscle pain.

Solo Slim was found to contain Sibutramine, which is approved by FDA to be used as an appetite suppressant in weight loss pills. Approved by FDA in 1997 , it can cause substantial increases in blood pressure and pulse rate, and can increase the risk of health problems in people who have suffered coronary artery disease, congestive heart failure, arrhythmias or stroke.

The recalled products include Revivexxx Extra Strength, which is sold in a single-dose with one tablet in a single-dose blister. It has a UPC of 8 35470 00207 9. Also recalled are Solo Slim and Solo Slim Extra Strength products, sold in white bottles with a blue screw-on cap. Solo Slim bottles have an UPC of 8 35470 00206 9 and Solo Slim Extra Strength bottles have an UPC of 8 35470 00220 5.

Both products were sold to retailers nationwide and sold online. The recall affects all of these products currently on the market.

Dietary supplements are designated as foods by FDA and do not need to receive FDA approval before being placed on the market. However, they must not contain undeclared drugs and cannot claim to treat, prevent or cure a disease.