FDA recall D-1367-2014

Pure Edge Nutrition · Class I · drug

Product

Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ

Reason for recall

Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2013-10-10
Report date
2014-06-18
Termination date
2016-10-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Toms River, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1367-2014