D-0470-2024 Class I Terminated
FDA drug recall D-0470-2024 was initiated by FA Online Inc on February 12, 2024 and is designated Class I. Reason for recall: 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 unappr… The recall status is terminated (terminated June 13, 2024). Affected quantity: 400 capsules.
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2024
- Initiation Date
- February 12, 2024
- Termination Date
- June 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400 capsules
Product Description
ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
Reason for Recall
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.
Distribution Pattern
USA Nationwide. The product was sold via Amazon Market Place.
Code Information
All lots within expiry