Why it was 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.
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 numbers, UPCs & expiration codes
Lot number: NPINPB 1003, Expiration date: 08/16/2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0453-2023
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 13, 2023
- FDA report date
- Mar 8, 2023
- Quantity
- 432 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Volt Candy Wholesale Club
Original FDA data
Every field from FDA enforcement report D-0453-2023, exactly as published.
Show all FDA fields
- City
- Diamond Bar
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 91711
- Address
- 324 S Diamond Bar Blvd
- Address (line 2)
- #212
- Code information
- Lot number: NPINPB 1003, Expiration date: 08/16/2025
- Postal code
- 91765-1607
- Report date
- Mar 8, 2023
- Product type
- Drugs
- Recall number
- D-0453-2023
- Classification
- Class I
- Recalling firm
- Volt Candy Wholesale Club
- Product quantity
- 432 capsules
- Termination date
- Aug 20, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 13, 2023
- Initial firm notification
- Press Release
- Center classification date
- Mar 9, 2023