FDA recall D-0881-2016

Product

Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010

Reason for recall

Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-09-23

Report date

2016-06-01

Termination date

2022-11-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arlington, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0881-2016