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.
Reported: March 8, 2023 Initiated: February 13, 2023 #D-0453-2023
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.
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.
Details
- Recalling Firm
- Volt Candy Wholesale Club
- Units Affected
- 432 capsules
- Distribution
- Nationwide in the USA
- Location
- Diamond Bar, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Volt Candy Wholesale Club. Units affected: 432 capsules.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 8, 2023. Severity: Critical. Recall number: D-0453-2023.
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