Status
Terminated
Drug Enforcement D-600-2013
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.
Classification
Class I
Report Date
June 19, 2013
Termination Date
October 1, 2019
Product Information
- 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
- Product quantity
- 600 boxes
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Nationwide, Puerto Rico and Venezuela and Bolivia
Location & Firm
- Recalling firm
- OLAAX International
- Address
-
6105 Riverlake Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-600-2013
- Event ID
- 64409
- Recall initiation date
- February 12, 2013
- Center classification date
- June 13, 2013
- Code info
- All Lots
- More code info
- —