D-0453-2023 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2023
- Initiation Date
- February 13, 2023
- Termination Date
- August 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 432 capsules
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.
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot number: NPINPB 1003, Expiration date: 08/16/2025