D-148-2013 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 13, 2013
- Initiation Date
- September 20, 2012
- Termination Date
- October 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,400 bottles
Product Description
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
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Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
Distribution Pattern
Nationwide and Puerto Rico and internationally to Barbados, Brazil, Canada, Cyprus, Equador, France, Germany, Israel, Mexico, and Netherlands.
Code Information
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.