Drug product
Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com
D-0345-2024
Product summary
- Firm
- Today The World
- Event
- Event 93941
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 5500 boxes
- Official record key
drug-enforcement:D-0345-2024
Official wording
Reason: 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.
Code information: Lot #: 2107, Exp. Date 10/31/2024.
Distribution pattern: Product distributed nationwide within the United States.
Derived failure modes
-
Unknown
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.