Products found to contain undeclared medicines
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| The United States: 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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The US Food and Drug Administration (FDA) announces that Newark, CA, Gadget Island, Inc. is voluntarily recalling the following products to the consumer level:
- Rhino 7 Platinum 5000 capsules (all lots)
- Papa Zen 3300 capsules (lot number: NSS050888; exp date: May 2018)
- Fifty Shades 6000 capsules (all lots)
- Grande X 5800 capsules (all lots)
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 products are marketed as dietary supplements for male sexual enhancement. The products were distributed nationwide via internet sales.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm579121.htm
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 21 Sep 2017.
Ends/Saturday, Oct 7, 2017
Issued at HKT 12:00
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