FDA recall D-0993-2015

REFA Enterprises, LLC · Class I · drug

Product

Forever Beautiful INFINITY, capsules, 300mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA

Reason for recall

Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2014-11-03
Report date
2015-05-13
Termination date
2015-11-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Virginia Beach, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0993-2015