Drug product
Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0
D-0396-2026
Product summary
- Firm
- Mohamed Hagar
- Event
- Event 97796
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 125 boxes
- Official record key
drug-enforcement:D-0396-2026
Official wording
Reason: Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Code information: ALL LOTS, exp 12/31/2027
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).