December 2013 FDA Recall Drug by Deseo Rebajar
D-1351-2014 - Marketed Without an Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Deseo Rebajar on December 23, 2013 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in Puerto Rico only and the recall is currently terminated.

Recall Number: D-1351-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement
Initiated
12-23-2013
Reported
06-04-2014
Quantity
120 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67162
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Deseo Rebajar
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Puerto Rico only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-03-2017
Product Description About Product Description
Full technical description of the product.
Burn 7 Capsules, supplied in 30 capsules bottle

Batch or Lot Expiration Information

Lot# MFD: 07.18.2013, EXP: 07.17.2015