Products found to contain undeclared medicines
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| The United States: R Thomas Marketing LLC in conjunction with Just Enhance LLC issues nationwide recall of Black Ant, Herb Viagra, Real Skill, Weekend Prince, African Black Ant And Stree Overlord along with multiple other products due to undeclared sildenafil |
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R Thomas Marketing LLC is voluntarily recalling all lots of the following products to the consumer level. These products were marketed as dietary supplements for male sexual enhancement, and are mainly sold be the company via internet sales.
• Black Ant: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules total)
• Herb Viagra: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)
• Real Skill: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)
• Stree Overlord: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)
• Weekend Prince: BIG BOX (24 individual cards / 2 capsules per card / 48 capsules)
• African Black Ant: BIG BOX (8 small boxes / 6 capsules per box / 48 capsules)
These products were tested by the FDA and found to contain Sildenafil, a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug. Sildenafil is not listed on the product labels. This undeclared active ingredient poses a threat to consumers because Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.
R Thomas Marketing is also recalling all lots of other products previously sold at the consumer level because these products were sourced from the same vendors as the above-mentioned products and may have resulted in similar misbranding or the likelihood for misbranding to occur in the future. Details of the products involved can be found at the FDA website.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm481054.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Monday, January 11, 2016
Issued at HKT 16:00
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