D-600-2013 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 19, 2013
- Initiation Date
- February 12, 2013
- Termination Date
- October 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 600 boxes
Product Description
MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL
Reason for Recall
Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
Distribution Pattern
Nationwide, Puerto Rico and Venezuela and Bolivia
Code Information
All Lots