PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Pr
Summary
The FDA issued a Class I for PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-coun by Volt Candy Wholesale Club. Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA.
Details
Source
Drug Recall
External ID
D-0453-2023
Action Date
2023-03-08
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot number: NPINPB 1003, Expiration date: 08/16/2025
Quantity Affected: 432 capsules
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.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-13
Company
Diamond Bar, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 123 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Volt Candy Wholesale Club) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Volt Candy Wholesale Club have FDA actions?
This is the only FDA action we have on record for Volt Candy Wholesale Club in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0453-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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