Drug product
maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028
D-0635-2021
Product summary
- Firm
- Miracle 8989
- Event
- Event 87981
- Status
- Terminated
- Classification
- Class I
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0635-2021
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.