Products found to contain undeclared medicines
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| The United States: Gadget Island, Inc. dba Gear Isle issues voluntary nationwide recall of dietary supplements due to undeclared active pharmaceutical ingredients sildenafil, desmethyl carbodenafil and tadalafil |
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The US Food and Drug Administration (FDA) announces that Newark, CA, Gadget Island, Inc. is voluntarily recalling the following products to the consumer level. The products have been found to contain undeclared active pharmaceutical ingredients sildenafil, desmethyl carbodenafil and tadalafil:
- Rhino 7 Platinum 5000 (LOT# R7-D5K1011H)
- Papa Zen 3000 (LOT# NSS050888)
- Fifty Shades 6000 (LOT# No Lot Number)
- Grande X 5800 (LOT# No Lot Number)
Use of products with undeclared active ingredients sildenafil, desmethyl carbodenafil and tadalafil 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 were distributed nationwide via internet sales.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm576785.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Thursday, Sep 21, 2017
Issued at HKT 16:00
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