Company recalls dietary supplements sold nationwide

Posted
Newark, California-based Gadget Island Inc. is voluntarily recalling a variety of dietary supplements due to undeclared active pharmaceutical ingredients. Such ingredients include sildenafil, desmethyl carbodenafil and tadalafil. Products distributed containing these undeclared ingredients include: * Rhino 7 Platinum 5000 - UPC 617135861224, LOT No. R7-D5K1011H. * Papa Zen 3000 - UPC 718122032587, LOT No. NSS050888 * Fifty Shades 6000 - UPC 4026666146056 *Grande X 5800 - UPC 640793555440 Use of products with undeclared active ingredients like 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. Among the adult male population who are most likely to use these products, those who use nitrates for cardiac conditions are the most at risk from these products. These products are considered tainted and the Food and Drug Administration has received adverse event reports from consumers who have purchased these products. To date, Gadget Island Inc., doing business as Gear Isle, has not received any reports of adverse events related to this recall. Consumers with questions regarding this recall can contact Gear Isle customer service by calling 1 (888) 387-4753 or email at info@gearisle.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program by visiting www.fda.gov/medwatch/report.htm.