FDA recall D-0345-2024

Today The World · Class I · drug

Product

Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com

Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.

Distribution

Product distributed nationwide within the United States.

Key facts

Status
Ongoing
Initiation date
2024-02-06
Report date
2024-02-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portland, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0345-2024