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Recall Observatory FDA recall evidence

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

February 12, 2013

Class I

Product summary

Firm
OLAAX International
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

    reason.no_named_rule · v1.0.0

    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.