FDA Recall D-0453-2023
Volt Candy Wholesale Club · Diamond Bar, CA
Class I — life-threatening Terminated 554 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
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 record
- Recall number
D-0453-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the USA
- Recall initiated
- 2023-02-13
- Classified by FDA Center
- 2023-03-09
- FDA published
- 2023-03-08
- Terminated
- 2024-08-20
- Recalling firm
- Volt Candy Wholesale Club
- Firm location
- Diamond Bar, CA