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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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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
Distribution Pattern Nationwide, Puerto Rico and Venezuela and Bolivia

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 All Lots Class I 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. 600 boxes D-600-2013