FDA recall D-0878-2016

Centro Naturista · Class I · drug

Product

Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011

Reason for recall

Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-06-03
Report date
2016-06-01
Termination date
2017-03-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dallas, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0878-2016