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  4. Gadget Island, Inc. Dba Gear Isle Issues Voluntary Nationwide Recall of Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredients.
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COMPANY ANNOUNCEMENT

Gadget Island, Inc. Dba Gear Isle Issues Voluntary Nationwide Recall of Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredients.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Gadget Island, Inc. Dba Gear Isle Issues Voluntary Nationwide Recall of Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredients.

Summary

Company Announcement Date:
September 20, 2017
FDA Publish Date:
February 07, 2018
Product Type:
Dietary Supplements
Reason for Announcement:
Recall Reason Description
Undeclared Sildenafil and Tadalafil
Company Name:
Gadget Island, Inc. dba Gear Isle
Brand Name:
Brand Name(s)
Rhino 7, Papa Zen, Fifty Shades, and Grand X
Product Description:
Product Description
Dietary Supplement

Company Announcement

Gadget Island, Inc. 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. 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. 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.

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. 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. These products are considered tainted and FDA has received adverse event reports from consumers who have purchased these products. To date, Gadget Island, Inc. dba Gear Isle has not received any reports of adverse events related to this recall.

The products are marketed as dietary supplements for male sexual enhancement and are packaged as indicated in the table below. The products can also be identified by using the attached images.  The products were distributed Nationwide via internet sales.

 

Product Package Size UPC Lot# and EXP. date
Rhino 7 Platinum 5000 1 capsule in blister pack 6 17135 86122 4 R7-D5K1011H EXP:12/2017
Papa Zen 3300 1 capsule in blister pack 7 18122 03258 7 NSS050888 EXP: May 2018
Fifty Shades 6000 1 capsule in blister pack 4 026666 146056 All Lots
Grande X 5800 1 capsule in blister pack 6 40793 55544 0 All Lots

Gadget Island, Inc. 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.

Consumers with questions regarding this recall can contact Gear Isle customer service by calling 888-387-4753 or email at info@gearisle.com on Monday to Friday from 10am to 4pm PST.  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 fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Link to Expanded Recall.

  • Fifty Shades, Front of package
  • Fifty Shades, Back of package with Supplement Facts
  • Grand X, Back of package with Supplement Facts
  • Grand X, Front of package
  • PapaZen, Back of package with Supplement Facts
  • Package Photo:  PapaZen, Front of package
  • Rhino 7, Back of package with Supplement Facts
  • Rhino 7, Front of package

 

Consumers

info@gearisle.com
888-387-4753