Status
Terminated
Drug Enforcement D-0453-2023
Marketed Without An Approved NDA/ANDA: FDA analysis found the 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.
Classification
Class I
Report Date
March 8, 2023
Termination Date
August 20, 2024
Product Information
- Product description
- PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.
- Product quantity
- 432 capsules
- Reason for recall
- Marketed Without An Approved NDA/ANDA: FDA analysis found the 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.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Volt Candy Wholesale Club
- Address
-
324 S Diamond Bar Blvd, #212
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0453-2023
- Event ID
- 91711
- Recall initiation date
- February 13, 2023
- Center classification date
- March 9, 2023
- Code info
- Lot number: NPINPB 1003, Expiration date: 08/16/2025
- More code info
- —