Drug 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
D-148-2013
Product summary
- Event
- Event 63048
- Status
- Terminated
- Classification
- Class I
- Quantity
- 40,400 bottles
- Official record key
drug-enforcement:D-148-2013
Official wording
Reason: Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
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.
Distribution pattern: Nationwide and Puerto Rico and internationally to Barbados, Brazil, Canada, Cyprus, Equador, France, Germany, Israel, Mexico, and Netherlands.
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.