FDA recall D-0246-2019
Zero Xtreme USA · Class II · drug
Product
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
Reason for recall
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
Distribution
Nationwide within the USA.
Key facts
- Status
- Terminated
- Initiation date
- 2018-10-15
- Report date
- 2018-11-21
- Termination date
- 2022-01-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Aventura, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0246-2019