Product Safety Recalls

Product Recall Tracker

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

Mandated?Voluntary: Firm initiated
Recall NumberD-0453-2023
Event ID91711
DistributionNationwide in the USA
Quantity432 capsules
Recall ReasonMarketed 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 ClassificationClass I
Drug Code Info20230308
Recall Initiation Date20230213
Report Date20230308
Classification Date20230309
Address324 S Diamond Bar Blvd#212
Diamond Bar, CA 91765-1607
United States
Recalling FirmVolt Candy Wholesale Club
Initial Notification Press Release
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