Arize Herbal capsules recalled due to undeclared Nortadalafil

Excerpt

The US FDA has published a company announcement from Today The World announcing that the company is voluntarily recalling one lot of Arize Herbal Dietary Supplement capsules (Lot 2107; expiry date 10/2024) after FDA analysis identified the presence of Nortadalafil, which is 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.Consumption of products with undeclared Nortadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin, and may cause potentially life-threatening hypotension. Men who use nitrates for cardiac conditions are most at risk. However, as of 2 February 2024, no adverse events related to use of Arize have been reported, said Today The World.Arize Herbal Dietary Supplement is marketed as a dietary supplement for male sexual enhancement, and was distributed in the US via the www.getarize.com website.Today The World is notifying its customers of this recall via press release and is arranging for the return and/or replacement of all recalled product. Consumers that have the recalled lot of Arize should stop using the capsules. They should contact their healthcare provider if they have experienced any problems that may be related to use of this product.Adverse reactions experienced with the use of this product should be reported to the FDA MedWatch Adverse Event Reporting program. …