Drug product
MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663
D-1603-2014
Product summary
- Event
- Event 67860
- Status
- Terminated
- Classification
- Class I
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1603-2014
Official wording
Reason: Marketed Without an Approved NDA/ANDA; Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.
Code information: Lot# 10081359
Distribution pattern: Nationwide to retailers and distributors
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA; Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.