FDA-Drug2023-03-08Class I
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.
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Hazard
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.
Sold states
Nationwide in the USA
Affected count
432 capsules
Manufactured in
324 S Diamond Bar Blvd, #212, Diamond Bar, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0453-2023Don't want to check this manually?
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