FDA recall D-1351-2014

Product

Burn 7 Capsules, supplied in 30 capsules bottle

Reason for recall

Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement

Distribution

Puerto Rico only

Key facts

Status

Terminated

Initiation date

2013-12-23

Report date

2014-06-04

Termination date

2017-05-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fajardo, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1351-2014