FDA received adverse event reports on one of two products marketed as dietary supplements that were recalled on Sept. 20 after being found spiked with drug ingredients indicated for erectile dysfunction. Gadget Island Inc. recalled five male sexual enhancement products found containing undeclared pharmaceutical ingredients sildenafil and tadalafil, which are approved by FDA for ED drugs, and desmethyl carbodenafil, a chemical structurally similar to sildenafil that is not an approved drug. The products are branded Rhino 7, Platinum 5000, Papa Zen 3000, Fifty Shades 6000 and Grande X 5800. The Newark, Calif, firm, which does business as Gear Isle, says it has received no AERs from consumers about the product but it is notifying customers by email and arranging returns and refunds all recalled products.
Separately, Natures Supplement Inc. recalled 260 bottles of Vegetable Vigra 200mg capsules tainted with sildenafil and distributed in Florida to...
