Why it was recalled
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Product description
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
Lot numbers, UPCs & expiration codes
All lots and manufacturing dates.
Where it was sold
Product distributed in NC and nationwide through the internet.
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-0210-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 13, 2016
- FDA report date
- Dec 28, 2016
- Quantity
- 25 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ultimate Body Tox
Original FDA data
Every field from FDA enforcement report D-0210-2017, exactly as published.
Show all FDA fields
- City
- Rowland
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 75832
- Address
- PO Box 637
- Code information
- All lots and manufacturing dates.
- Postal code
- 28383-0637
- Report date
- Dec 28, 2016
- Product type
- Drugs
- Recall number
- D-0210-2017
- Classification
- Class I
- Recalling firm
- Ultimate Body Tox
- Product quantity
- 25 bottles
- Termination date
- Jul 27, 2017
- Reason for recall
- Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
- Distribution pattern
- Product distributed in NC and nationwide through the internet.
- Recall initiation date
- Nov 13, 2016
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 22, 2016