Shogun-X 7000 and Thumbs Up 7 Recalled Due to Risks of Deadly Undisclosed Tadalafil, Sildenafil, and/ or Vardenafil
WASHINGTON, DC – According to an urgent recall announcement published by the U.S. Food and Drug Administration, Nuri Trading LLC is recalling its “Thumbs Up 7, Shogun-X, 69MODE” products due to undeclared PDE-5 inhibitors such as Sildenafil, Tadalafil, Vardenafil. If a consumer, who is taking nitrates or nitroglycerin, accidentally consumes a PDE-5 inhibitor, the user could suffer a life-threatening lowering of their blood pressure. PDE-5 inhibitors such as Sildenafil, Tadalafil, Vardenafil can interact with nitrates found in some prescription drugs such as nitroglycerin. Patients who have diabetes, heart disease, and/or high blood pressure often take nitrates.
The recalled products are male sexual enhancement supplements. The brand names recalled include Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69. These capsules became an unapproved drug once they are discovered to have phosphodiesterase (PDE-5) inhibitors. All drugs must be reviewed by the FDA and checked for both safety and efficacy. The recalled supplements have not been established and approved, which makes the products subject to a recall.
Nuri Trading is recalling all lots of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69 capsules regardless of the product’s expiration date. The recall affects customers at the consumer level. The FDA analyzed the products and discovered the supplements contained undeclared amounts of Tadalafil, Sildenafil, and/or Vardenafil. The medications are used in FDA-approved medications that treat male erectile dysfunction. Nuri Trading states that the company has not received reports of adverse events associated with the recall.
These products were sold and distributed via the internet and fulfilled by Amazon.com throughout the United States. On December 17, 2020, the FDA issued a news release warning consumer of certain products found on eBay, Amazon, and other online retailers due to potentially dangerous and hidden drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Customers are urged to throw away the supplements or visit nuritradingusa.com for a refund.
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