Products found to contain undeclared medicines
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| The United States: Nuri Trading LLC issues voluntary nationwide recall of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, 69MODE Blue 69, due to the presence of undeclared tadalafil, sildenafil, and/or vardenafil |
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The US Food and Drug Administration (FDA) announces that Nuri Trading is voluntarily recalling all lots within expiry of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69 capsules to the consumer level. FDA analyses have found these products to contain undeclared tadalafil, sildenafil, and/or vardenafil. Sildenafil, tadalafil and vardenafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.The presence of sildenafil, tadalafil, and/or vardenafil in Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69 capsules make them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.
Consumers with underlying medical issues who take Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, 69MODE Blue 69 capsules with undeclared sildenafil, tadalafil, and/or vardenafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Nuri Trading has not received any reports of adverse events related to this recall.
These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged in blister foil sheets in a box. Each box contains 10 capsules.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nuri-trading-llc-issues-voluntary-nationwide-recall-shogun-x-7000-thumbs-7-black-25k-thumbs-7-white
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Thursday, Apr 1, 2021
Issued at HKT 16:00
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