![]() ![]() ![]() This recall is being conducted with the knowledge of the U.S. Regular Mail or Fax: Download form or call 1-80 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-80 An immersion into the extraordinary South African wilderness featuring opportunities to connect with nature, engage in local cultures, and gain insights. ![]() Complete and submit the report Online:.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.Īdverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event fax. dba Gear Isle is notifying its customers by email and is arranging for return and refunds of all recalled products. Consumers that have product (see table) which is being recalled should stop using and return to PO Box 1156 Newark CA 94560 for a refund.Ĭonsumers with questions regarding this recall can contact Gear Isle customer service by calling 88 or email at on Monday to Friday from 10am to 4pm PST. The products were distributed Nationwide via internet sales. 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. Gear Isle, doing business as Gadget Island. 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. Septemby Linda Larsen Gadget Island, dba Gear Isle, is recalling four dietary supplements because they contain sildenafil, desmethyl carbodenafil and tadalafil. 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, LOT# R7-D5K1011H, Papa Zen 3300 capsules, LOT# NSS050888, Fifty Shades 6000 capsules, all Lots, Grande X 5800 capsules, all Lots, to the consumer level. ![]()
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