Drug product
Fruta BIO 400 mg capsules, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
D-1373-2014
Product summary
- Firm
- MyNicNaxs, Inc.
- Event
- Event 67471
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2 boxes
- Official record key
drug-enforcement:D-1373-2014
Official wording
Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein .
Code information: ALL LOTS
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein .