FDA recall D-165-2013

Product

SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA.

Reason for recall

Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.

Distribution

Korea

Key facts

Status

Terminated

Initiation date

2012-12-19

Report date

2013-02-27

Termination date

2013-03-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fullerton, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-165-2013