Drug product
ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
D-0470-2024
Product summary
- Firm
- FA Online Inc
- Event
- Event 94339
- Status
- Terminated
- Classification
- Class I
- Quantity
- 400 capsules
- Official record key
drug-enforcement:D-0470-2024
Official wording
Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
Code information: All lots within expiry
Distribution pattern: USA Nationwide. The product was sold via Amazon Market Place.
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.