Status
Terminated
Drug Enforcement D-0470-2024
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.
Classification
Class I
Report Date
May 1, 2024
Termination Date
June 13, 2024
Product Information
- Product description
- ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
- Product quantity
- 400 capsules
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- USA Nationwide. The product was sold via Amazon Market Place.
Location & Firm
- Recalling firm
- FA Online Inc
- Address
-
6520 180th St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0470-2024
- Event ID
- 94339
- Recall initiation date
- February 12, 2024
- Center classification date
- April 23, 2024
- Code info
- All lots within expiry
- More code info
- —