Drug product
PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
D-0633-2021
Product summary
- Firm
- Miracle 8989
- Event
- Event 87981
- Status
- Terminated
- Classification
- Class I
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0633-2021
Official wording
Reason: Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Code information: All lots remaining within expiry.
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.