D-1277-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 7, 2014
- Initiation Date
- November 7, 2013
- Termination Date
- May 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,146 bottles
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 052012, Exp 10/2015