Drug product
Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.
D-1277-2014
Product summary
- Firm
- Deseo Rebajar
- Event
- Event 66817
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,146 bottles
- Official record key
drug-enforcement:D-1277-2014
Official wording
Reason: Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.
Code information: Lot #: 052012, Exp 10/2015
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.