FDA recall D-0722-2016

Product

Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.

Reason for recall

Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug.

Distribution

Nationwide in the U.S.A. via the website.

Key facts

Status

Terminated

Initiation date

2015-09-29

Report date

2016-02-24

Termination date

2016-03-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mc Lean, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0722-2016