Why it was recalled
Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide and Puerto Rico and internationally to Barbados, Brazil, Canada, Cyprus, Equador, France, Germany, Israel, Mexico, and Netherlands.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-148-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 20, 2012
- FDA report date
- Feb 13, 2013
- Quantity
- 40,400 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Globe All Wellness, LLC
Original FDA data
Every field from FDA enforcement report D-148-2013, exactly as published.
Show all FDA fields
- City
- Hollywood
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 63048
- Address
- 2854 Stirling Rd
- Address (line 2)
- Suite G
- 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.
- Postal code
- 33020-1138
- Report date
- Feb 13, 2013
- Product type
- Drugs
- Recall number
- D-148-2013
- Classification
- Class I
- Recalling firm
- Globe All Wellness, LLC
- Product quantity
- 40,400 bottles
- Termination date
- Oct 2, 2019
- 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- Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide and Puerto Rico and internationally to Barbados, Brazil, Canada, Cyprus, Equador, France, Germany, Israel, Mexico, and Netherlands.
- Recall initiation date
- Sep 20, 2012
- Initial firm notification
- Telephone
- Center classification date
- Feb 5, 2013