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  4. Gadget Island, Inc. dba Gear Isle Issues Voluntary Nationwide Recall of Rhino 7 Platinum 5000, Papa Zen 3300, Fifty Shades 6000 and Grande X 5800, Due to Presence of Undeclared Sildenafil, Tadalafil and Desmethyl Carbodenafil
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COMPANY ANNOUNCEMENT

Gadget Island, Inc. dba Gear Isle Issues Voluntary Nationwide Recall of Rhino 7 Platinum 5000, Papa Zen 3300, Fifty Shades 6000 and Grande X 5800, Due to Presence of Undeclared Sildenafil, Tadalafil and Desmethyl Carbodenafil

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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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Food & Beverage Safety
Reason for Announcement:
Recall Reason Description
Unapproved new drug
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

Newark, CA, Gadget Island, Inc. is voluntarily recalling Rhino 7 Platinum 5000 capsules, All LOTS, 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 All Lots
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

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 Original Recall.

Consumers

Name
info@gearisle.com
888-387-4753
 

Product Photos