Newark, CA, Gadget Island, Inc. is voluntarily recalling to the consumer level. The products have been found to contain undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
- Rhino 7 Platinum 5000, UPC 617135861224, LOT# R7-D5K1011H
- Papa Zen 3000, UPC 718122032587, LOT# NSS050888
- Fifty Shades 6000, UPC 4026666146056, LOT# No Lot Number
- Grande X 5800, UPC 640793555440, LOT# No Lot Number
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 product is labeled as a dietary supplement and is packaged as indicated in the table below. The product can also be identified by using the attached images. The products were distributed Nationwide via internet sales.
| Product | Package size | UPC | Lot # |
|---|---|---|---|
| Rhino 7 Platinum 5000 | 1 blister pack capsule | 617135861224 | R7-D5K1011H |
| Papa Zen 3000 | 1 blister pack capsule | 718122032587 | NSS050888 |
| Fifty Shades 6000 | 1 blister pack capsule | 4026666146056 | No Lot Number |
| Grande X 5800 | 1 blister pack capsule | 640793555440 | No Lot Number |
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 [email protected] 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 Reporting program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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