Why it was recalled
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Product description
PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006
Lot numbers, UPCs & expiration codes
Lot #: GATCO 01671, Exp Date 12/30/2024 Serial # 728175421856
Where it was sold
Nationwide with the United States
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-0353-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 30, 2021
- FDA report date
- May 5, 2021
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Na Na Collection
Original FDA data
Every field from FDA enforcement report D-0353-2021, exactly as published.
Show all FDA fields
- City
- Elmwood Park
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 87653
- Address
- 495 Mola Blvd
- Address (line 2)
- Unit #3
- Code information
- Lot #: GATCO 01671, Exp Date 12/30/2024 Serial # 728175421856
- Postal code
- 07407-2041
- Report date
- May 5, 2021
- Product type
- Drugs
- Recall number
- D-0353-2021
- Classification
- Class II
- Recalling firm
- Na Na Collection
- Reason for recall
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006
- Distribution pattern
- Nationwide with the United States
- Recall initiation date
- Mar 30, 2021
- Initial firm notification
- Press Release
- Center classification date
- Apr 26, 2021