FDAFDA · Food and drugs·Recall number D-0453-2023
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.
Published March 8, 2023 · Recall initiated: February 13, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Volt Candy Wholesale Club
- Distributor
- Nationwide in the USA
- Lot
- Lot number: NPINPB 1003, Expiration date: 08/16/2025
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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