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Sex pills recalled for having ingredients that could cause unintended consequences

Nuri Trading recalled all lots within expiration period of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K and 69MODE Blue 69 capsules after FDA found undeclared tadalafil, sildenafil, and/or vardenafil ingredients.
Nuri Trading recalled all lots within expiration period of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K and 69MODE Blue 69 capsules after FDA found undeclared tadalafil, sildenafil, and/or vardenafil ingredients. Nuri Trading

Nuri Trading, a Korean company that sells male sexual enhancement products online and via Amazon, recalled all lots of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K and 69MODE Blue 69 capsules.

On March 29, the U.S. Food and Drug Administration found undeclared tadalafil, sildenafil and/or vardenafi ingredients, which are FDA-approved products — PDE-5 inhibitors — used for the treatment of male erectile dysfunction in products like Viagra and Cialis.

While those ingredients in other approved products may help men achieve the desired result, the presence of them in “unapproved new drugs for which the safety and efficacy have not been established” make them “subject to recall,” the FDA said in its notice, which posted on Wednesday.

Consumers with underlying medical issues who take the Shogun-X 7000, Thumbs Up 7 or 69MODE Blue 69 dietary supplement capsules could experience serious health risks, the FDA said.

The risks are similar to those named in TV commercials for the familiar Viagra, Cialis pills.

“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.,” the FDA said. “Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

So far, Nuri Trading has not received any reports of adverse events related to this recall, according to the FDA.

What to look for

Shogun-X capsules were recalled for having undeclared ingredients on March 31, 2019.
Shogun-X capsules were recalled for having undeclared ingredients on March 31, 2019. FDA

The tainted products are marketed as dietary supplements for male sexual enhancement and are packaged in blister foil sheets in a box containing 10 capsules.

Consumers are urged to stop using the recalled capsules and destroy them.

Questions? Contact Nuri Trading 201-380-1046 from 9 a.m. to 5 p.m. eastern time Monday-Friday or e-mail nuritrading17@gmail.com.

Call your physicians or healthcare provider if you’ve experienced any problems that may be related to taking these supplements.

In January 2019, a now dissolved company, Happy Together, issued a recall for the same reason: its male sexual enhancement drugs, Rhino 5k, had sildenafil and tadalafil, the active ingredients in Viagra and Cialis, respectively.

This story was originally published April 1, 2021 at 1:38 PM with the headline "Sex pills recalled for having ingredients that could cause unintended consequences."

Howard Cohen
Miami Herald
Miami Herald consumer trends reporter Howard Cohen, a 2017 Media Excellence Awards winner, has covered pop music, theater, health and fitness, obituaries, municipal government, breaking news and general assignment. He started his career in the Features department at the Miami Herald in 1991. Cohen is an adjunct professor at the University of Miami School of Communication. Support my work with a digital subscription
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