Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www...
FDA Recall #D-1277-2014 — Class I — November 7, 2013
Product Description
Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.
Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.
Recalling Firm
Deseo Rebajar — Fajardo, PR
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
1,146 bottles
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: 052012, Exp 10/2015
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated