- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionUndeclared Sildenafil, Tadalafil, Vardenafil
- Company Name:
- Nuri Trading LLC
- Brand Name:
Brand Name(s)Thumbs Up 7, Shogun-X, 69MODE
- Product Description:
Product DescriptionDietary Supplement for male sexual enhancement
Nuri Trading is voluntarily recalling all lots and all packaging presentations within expiry of Shogun-X Platinum 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69capsules to the consumer level.FDA analyses have found these products to contain undeclaredtadalafil, sildenafil, and/orvardenafil.Sildenafil,tadalafil,and vardenafilare ingredients known as phosphodiesterase (PDE-5) inhibitors found inFDA approved products for the treatment of male erectile dysfunction.The presence of sildenafil, tadalafil, and/ orvardenafil in Shogun-X Platinum 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69capsules 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 Platinum 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, 69MODE Blue 69capsules with undeclared sildenafil,tadalafil, and/or vardenafilmay 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. All size presentations are included in the recall, including but not limited to the1-count blister cards and 10-countblister foil sheets in a box. These products were distributed via internet and fulfilled by amazon at nationwide in the USA. 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. It also encouraged online marketplaces to ensure these products are not sold on their platforms.
Nuri Trading LLC is notifying its customers by this press announcement and via email of this recall. Consumers that have Shogun-X Platinum 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, or 69MODE Blue 69, which are being recalled should stop using and destroy them.
Consumers with questions regarding this recall can contact Nuri Trading by phone at (201) 380-1046 Monday to Friday from 9AM to 5PM [MA1] or e-mail firstname.lastname@example.org. For more information, please visit www.nuritradingusa.com. Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to takin or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
- Nuri Trading