FDA MedWatch – Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, 69MODE Blue 69 by Nuri Trading:

TOPIC: Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, 69MODE Blue 69 by Nuri Trading: Recall – Due to Presence of Undeclared Tadalafil, Sildenafil, and/ or Vardenafil

AUDIENCE: Consumer, Health Professional 

ISSUE: Nuri Trading is recalling all lots within expiry of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69 capsules because FDA analyses have found these products to contain undeclared tadalafil, sildenafil, and/or vardenafil. 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, phosphodiesterase (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. 

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: Sildenafil, tadalafil, and vardenafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.

These tainted products are marketed as dietary supplements for male sexual enhancement.

RECOMMENDATIONS: On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients.

• Consumers that have Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, 69MODE Blue 69, which are being recalled should stop using and destroy them.
• Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.