Burn 7 Capsules, supplied in 30 capsules bottle
FDA Recall #D-1351-2014 — Class I — December 23, 2013
Product Description
Burn 7 Capsules, supplied in 30 capsules bottle
Reason for Recall
Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 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
120 bottles
Distribution
Puerto Rico only
Code Information
MFD: 07.18.2013, EXP: 07.17.2015
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated