Gadget Island, Inc: Drug Recall
Recall #D-0572-2023 · 04/26/2023
Class I: Dangerous
Recall Details
- Recall Number
- D-0572-2023
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Gadget Island, Inc
- Status
- Ongoing
- Date Initiated
- 04/26/2023
- Location
- West Sacramento, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 blister cards
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.
Product Description
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
Distribution Pattern
Nationwide in the USA.
Other Recalls by Gadget Island, Inc
- Class I: Dangerous 04/26/2023
- Class I: Dangerous 04/26/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.