D-1366-2014 Class I Terminated

Recalled by Pure Edge Nutrition — Toms River, NJ

Recall Details

Product Type
Drugs
Report Date
June 18, 2014
Initiation Date
October 10, 2013
Termination Date
October 7, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
unknown

Product Description

Bella Vi BTrim MAX 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 Pattern

Nationwide

Code Information

lot # BTX13 EXP: 2015/08/15