Drug product
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
D-600-2013
Product summary
- Event
- Event 64409
- Status
- Terminated
- Classification
- Class I
- Quantity
- 600 boxes
- Official record key
drug-enforcement:D-600-2013
Official wording
Reason: 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.
Code information: All Lots
Distribution pattern: Nationwide, Puerto Rico and Venezuela and Bolivia
Derived failure modes
-
Unknown
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.