FDA recall D-0473-2017
Jersey Shore Supplements, LLC · Class I · drug
Product
SLIMFIT X capsules, packaged in a 60-cont bottle
Reason for recall
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Distribution
New Jersey and Maryland.
Key facts
- Status
- Terminated
- Initiation date
- 2016-12-09
- Report date
- 2017-02-22
- Termination date
- 2020-11-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Bradley Beach, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0473-2017