The products were distributed Nationwide via internet sales.Ĭonsumers with questions regarding this recall can contact Gear Isle customer service by calling 88 or email at i on Monday to Friday from 10am to 4pm PST. The products can also be identified by using the attached images.

The products are marketed as dietary supplements for male sexual enhancement and are packaged as indicated in the table below.

dba Gear Isle has not received any reports of adverse events related to this recall. These products are considered tainted and FDA has received adverse event reports from consumers who have purchased these products. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products. Risk Statement: Use of products with undeclared active ingredients sildenafil, tadalafil and desmethyl carbodenafil may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. The presence of Sildenafil, Tadalafil and or Desmethyl Carbodenafil in Rhino 7 Platinum 5000, Papa Zen 3300, Fifty Shades 6000, and Grande X 5800, renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall. FDA analysis has found the products to be tainted with Sildenafil and Tadalafil, which are the active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED), as well as Desmethyl Carbodenafil which is structurally similar to sildenafil.

is voluntarily recalling Rhino 7 Platinum 5000 capsules, All LOTS, Papa Zen 3300 capsules, LOT# NSS050888, Fifty Shades 6000 capsules, all Lots, Grande X 5800 capsules, all Lots, to the consumer level.

Rhino 7 platinum 5000 for sale