[Posted 09/20/2017]
AUDIENCE: Consumers
ISSUE: 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.
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.
BACKGROUND:The products are labeled as a dietary supplement and each is packaged as 1 blister pack capsule.
Product names and lot numbers include:
- 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
RECOMMENDATION: 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 these products and are encouraged to report any adverse events to FDA’s MedWatch Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form 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.
[09/20/2017 - Recall - Gadget Island Inc]
