Today The World Issues Voluntary Nationwide Recall of All Lots of Arize Herbal Dietary Supplement Capsules Due to the Presence of Undeclared Nortadalafil

Summary

Company Announcement

FOR IMMEDIATE RELEASE – Feb 2, 2024 – VANCOUVER, WA, “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 (structurally similar to Tadalafil). Nortadalafil 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. To date, no adverse events have been reported.

This tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged and coded as follows:

The product was distributed via website www.getarize.com in the USA. 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”.

Today The World is notifying its customers of this recall via press release and is arranging for return/replacement etc. of all recalled product. Consumers that have Arize which is being recalled should stop using them. Product can be returned to Today The World, 11954 NE Glisan St # 405 Portland OR 97220 or destroyed. When returning Arize products, include the blister pack foil (with any remaining pills) containing the recalled lot number and receipt/proof of purchase, and your return address.

Consumers with questions regarding this recall can contact “Today The World” by e-mail [email protected] or customers can call: 1-888-767-4889 between the hours of 10 a.m. and 5 p.m. Pacific Standard Time for instructions on the return and refund process. 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.

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.