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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Product Detail

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
Recall Number D-600-2013
Classification Class I
Code Info All Lots
Product Distributed Qty 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.

Event Detail

Event Id 64409
Product Type Drugs
Status Ongoing
Recalling Firm OLAAX International
City Bartow
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-12
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Nationwide, Puerto Rico and Venezuela and Bolivia