FDA recall D-0675-2016

Inaffit, LLC · Class I · drug

Product

NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827.

Reason for recall

Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-10-05
Report date
2016-02-24
Termination date
2016-03-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gaithersburg, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0675-2016