FDA recall D-1369-2014

Pure Edge Nutrition · Class I · drug

Product

Bella Vi INSANE AMP'D Dietary Supplement capsules, 60 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-1369-2014