Recall D-0453-2023
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.
Recall D-0453-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0453-2023 |
| Event ID | 91711 |
| Distribution | Nationwide in the USA |
| Quantity | 432 capsules |
| Recall 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. |
| Drug Classification | Class I |
| Drug Code Info | 20230308 |
| Recall Initiation Date | 20230213 |
| Report Date | 20230308 |
| Classification Date | 20230309 |
| Address | 324 S Diamond Bar Blvd#212 Diamond Bar, CA 91765-1607 United States |
| Recalling Firm | Volt Candy Wholesale Club |
| Initial Notification | Press Release |
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