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.
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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.
LatoriaJanuary 1, 2022 at 8:47 am
I really hate that this product was recalled.I have always struggled with my weight and this is the only product that has helped me lose weight! Is there anything else that works like this product does?
BillNovember 28, 2021 at 1:34 am
I used Solo Slim Original back in 2009-2010 and it worked Great. They took it off the market instead of putting warning labels like they used to. Great product looking for more
joSeptember 19, 2012 at 4:06 pm
just saw these articles...really just now able to read...i was taking solo slim aug 12 suffered massive stroke wast in gym everyday was healthy so got my new pa to look this med up to see if ok to take because of condition and she said it recalled...well now pondering lots of thoughts..severe enough that i now on disability at age 47
k hawkNovember 24, 2010 at 3:12 am
I'm not sure about no on being hurt due to the use of solo slim, the internet is full of complaints and even fatalities possibly associated with the use of the product. Personally I would like to see a class action suit formed against the company for including prescription medication in a guaranteed "all natural" product. The company has now reformulated the product, is charging more for it and it[Show More]I'm not sure about no on being hurt due to the use of solo slim, the internet is full of complaints and even fatalities possibly associated with the use of the product. Personally I would like to see a class action suit formed against the company for including prescription medication in a guaranteed "all natural" product. The company has now reformulated the product, is charging more for it and it no longer works. These companies need to understand there are consequences for defrauding the public.
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