Gadget Island, Inc. Dba Gear Isle Issues Voluntary Nationwide Recall of Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredients.
- Company Announcement Date:
- September 20, 2017
- FDA Publish Date:
- February 07, 2018
- Reason for Announcement:
- 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 DescriptionDietary Supplement
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 firstname.lastname@example.org 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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Link to Expanded Recall.