FDA Recall D-148-2013

Product

SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product Forumulated and Distributed By: Globe All Wellness, LLC Hollywood, FL 33020 www.diet66.com Inquires Call 877.842.9873

Lot / code: All Lots of SlimXtreme with the following format stamped in black ink on the bottom of the bottle "MFD: XX.XX.20XX EXP: XX.XX.20XX", which were manufactured overseas, are being recalled.

Quantity: 40,400 bottles

Reason for recall

Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.

Recall record

Recall number

D-148-2013

Classification

Class I

Status

Terminated

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Telephone

Distribution

Nationwide and Puerto Rico and internationally to Barbados, Brazil, Canada, Cyprus, Equador, France, Germany, Israel, Mexico, and Netherlands.

Recall initiated

2012-09-20

Classified by FDA Center

2013-02-05

FDA published

2013-02-13

Terminated

2019-10-02

Recalling firm

Globe All Wellness, LLC

Firm location

Hollywood, FL