FDA recall D-0882-2016

Product

Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010

Reason for recall

Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-12-09

Report date

2016-06-01

Termination date

2021-09-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arlington, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0882-2016