Why it was recalled
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Product description
PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
Lot numbers, UPCs & expiration codes
all lots
Where it was sold
USA Nationwide
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-0382-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 6, 2021
- FDA report date
- May 26, 2021
- Quantity
- 500 cards
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hyobin LLC
Original FDA data
Every field from FDA enforcement report D-0382-2021, exactly as published.
Show all FDA fields
- City
- Ridgewood
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 87711
- Address
- 455 S Pleasant Ave
- Code information
- all lots
- Postal code
- 07450-5413
- Report date
- May 26, 2021
- Product type
- Drugs
- Recall number
- D-0382-2021
- Classification
- Class II
- Recalling firm
- Hyobin LLC
- Product quantity
- 500 cards
- Reason for recall
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Apr 6, 2021
- Initial firm notification
- Press Release
- Center classification date
- May 14, 2021