FDA recall D-1277-2014

Product

Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.

Reason for recall

Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-11-07

Report date

2014-05-07

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-1277-2014