FDA recall D-600-2013

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.

Distribution

Nationwide, Puerto Rico and Venezuela and Bolivia

Key facts

Status

Terminated

Initiation date

2013-02-12

Report date

2013-06-19

Termination date

2019-10-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bartow, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-600-2013