D-1351-2014 Class I Terminated

Recalled by Deseo Rebajar — Fajardo, PR

Recall Details

Product Type
Drugs
Report Date
June 4, 2014
Initiation Date
December 23, 2013
Termination Date
May 3, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
120 bottles

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

Distribution Pattern

Puerto Rico only

Code Information

MFD: 07.18.2013, EXP: 07.17.2015