FDA Recall D-600-2013
OLAAX International · Bartow, FL
Class I — life-threatening Terminated 2422 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
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 record
- Recall number
D-600-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Nationwide, Puerto Rico and Venezuela and Bolivia
- Recall initiated
- 2013-02-12
- Classified by FDA Center
- 2013-06-13
- FDA published
- 2013-06-19
- Terminated
- 2019-10-01
- Recalling firm
- OLAAX International
- Firm location
- Bartow, FL