D-0572-2023 Class I Ongoing
FDA drug recall D-0572-2023 was initiated by Gadget Island, Inc on April 26, 2023 and is designated Class I. Reason for recall: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual en… The recall status is ongoing. Affected quantity: 18 blister cards.
Recall Details
- Product Type
- Drugs
- Report Date
- May 10, 2023
- Initiation Date
- April 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 blister cards
Product Description
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
Reason for Recall
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot#: RO 927996, Exp: 12/25/2024