Drug product
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.
D-0453-2023
Product summary
- Event
- Event 91711
- Status
- Terminated
- Classification
- Class I
- Quantity
- 432 capsules
- Official record key
drug-enforcement:D-0453-2023
Official wording
Reason: 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.
Code information: Lot number: NPINPB 1003, Expiration date: 08/16/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
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.