Gadget Island Inc., doing business as Gear Isle, is recalling four brands of dietary supplements because they are laced with several hidden drugs that can cause life-threatening side effects in some people.
The recall affects the following Gadget Island supplements:
- Rhino 7 Platinum 5000, UPC 617135861224, LOT# R7-D5K1011H
- Papa Zen 3000, UPC 718122032587, LOT# NSS050888
- Fifty Shades 6000, UPC 4026666146056, LOT# No Lot Number
- Grande X 5800, UPC 640793555440, LOT# No Lot Number
A Food and Drug Administration (FDA) laboratory analysis has determined the supplements to contain undeclared sildenafil, tadalafil and desmethyl carbodenafil. Sildenafil and tadalafil are the active ingredients in the prescription erectile dysfunction drugs Viagra and Cialis, respectively. Desmethyl carbodenafil is an analogue of sildenafil.
All three of these drugs can interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
The FDA has received reports of adverse events in consumers who have purchased these products. Anyone who has taken these supplements and experienced any side effects or adverse events should file a report with the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Gadget Island is notifying its customers by email and arranging for returns and refunds. Consumers who have the products should stop using them immediately and return them to P.O. Box 1156 Newark, CA 94560 for a full refund.
Source: FDA Recall Notice