Gadget Island Inc., doing business as Gear Isle, is expanding a recall of some of its male sexual enhancement products because they are laced with hidden drugs that can cause life-threatening risks to some people. The products were distributed nationwide through internet sales.
The recall originally initiated in September, was expanded this week to include more lots of the dietary supplements previously named. The recall now includes the following supplements and lot numbers:
- Rhino 7 Platinum 5000 capsules, all lots
- Papa Zen 3300 capsules, Lot# NSS050888
- Fifty Shades 6000 capsules, all lots
- Grand X 5800 capsules, all lots
The previous recall included the following products and lot numbers:
- Rhino 7 Platinum 5000, Lot# R7-D5K1011H
- Papa Zen 3000, Lot# NSS050888
- Fifty Shades 6000, Lot# No Lot Number
- Grande X 5800, Lot# No Lot Number
A laboratory analysis conducted by the Food and Drug Administration (FDA) determined that the supplements contain sildenafil, tadalafil, and desmethyl carbodenafil. Sildenafil and tadalafil are the active ingredients in the prescription erectile dysfunction drugs Viagra and Cialis. Desmethyl carbodenafil is a chemical that is structurally similar to sildenafil and carries similar risks.
Use of these products with undeclared sildenafil, tadalafil, and desmethyl carbodenafil may pose a risk to consumers because the active ingredient can interact with nitrates that are found in some prescription drugs including nitroglycerin, resulting in a significant drop in blood pressure that can be life-threatening. People with cardiac conditions such as high blood pressure, high cholesterol and diabetes are more likely to take nitrates.
The FDA has received adverse event reports from consumers who have purchased these products. To date, Gadget Island has not. Any consumers who have these products in their possession should stop taking them immediately, and contact their doctors if they are experiencing any health concerns. Any adverse events should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
FDA Recall Notice