FDA recall D-0108-2017
Dream Body Weight Loss · Class II · drug
Product
Dream Body Advanced 400 mg 30 capsules in brown foil packets.
Reason for recall
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Distribution
United States
Key facts
- Status
- Terminated
- Initiation date
- 2016-07-01
- Report date
- 2016-10-26
- Termination date
- 2021-09-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Grand Prairie, TX, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0108-2017