Volt Candy Wholesale Club: Drug Recall
Recall #D-0453-2023 · 02/13/2023
Class I: Dangerous
Recall Details
- Recall Number
- D-0453-2023
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Volt Candy Wholesale Club
- Status
- Terminated
- Date Initiated
- 02/13/2023
- Location
- Diamond Bar, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- 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.
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.
Distribution Pattern
Nationwide in the USA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.