Drug product
Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida
D-0664-2016
Product summary
- Event
- Event 71733
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 783 bottles
- Official record key
drug-enforcement:D-0664-2016
Official wording
Reason: Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.
Code information: Lot # 000815004400; Exp 12/17
Distribution pattern: Nationwide and Colombia, South America
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.