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Safety Report: Arize male enhancement capsules - recalled due to undeclared Nortadalafil, USA

4 months ago source fda.gov

Recall notice

United States

"Today The World” is voluntarily recalling one lot of Arize Herbal Dietary Supplement capsules to the consumer level. FDA analysis has found the products to contain undeclared Nortadalafil. The product was distributed online via their website in the USA. To date, no adverse events have been reported.

Nortadalafil (structurally similar to Tadalafil) is an active drug ingredient known for treatment of male erectile dysfunction. The presence of Nortadalafil in Arize makes this an unapproved new drug for which the safety and efficacy has not been established and, therefore subject to recall.

Risk Statement: Consumption of products with undeclared nortadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life-threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.

This tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged and coded as Attached. The product can be identified by –black box with the word Arize written in red on the front with a line underneath which reads: “For a rise that is hard to forget”.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

In case you experience harm from allergens or undeclared ingredients, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Today the World
Brand name: Arize
Product recalled: Arize brand male enhancement capsules
Reason of the recall: Products contain undeclared Nortadalafil
FDA Recall date: February 05, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/today-world-issues-voluntary-nationwide-recall-all-lots-arize-herbal-dietary-supplement-capsules-due

#drugs #recall #us

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