Drug product
MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663
D-1614-2014
Product summary
- Event
- Event 68218
- Status
- Terminated
- Classification
- Class I
- Quantity
- 57 boxes
- Official record key
drug-enforcement:D-1614-2014
Official wording
Reason: Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Code information: All lots
Distribution pattern: To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.