Drug product
Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
D-0877-2016
Product summary
- Firm
- Centro Naturista
- Event
- Event 71401
- Status
- Terminated
- Classification
- Class I
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0877-2016
Official wording
Reason: Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Code information: All lots
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.