Drug product
SLIMFIT X capsules, packaged in a 60-cont bottle
D-0473-2017
Product summary
- Event
- Event 75929
- Status
- Terminated
- Classification
- Class I
- Quantity
- 150 bottles
- Official record key
drug-enforcement:D-0473-2017
Official wording
Reason: Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Code information: All lots and all expiration dates.
Distribution pattern: New Jersey and Maryland.
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.