Why it was recalled
Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared 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.
Product description
Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.
Lot numbers, UPCs & expiration codes
Lot #: 05/02/2015 to 05/01/2017
Where it was sold
Nationwide in the U.S.A. via the website.
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-0722-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 29, 2015
- FDA report date
- Feb 24, 2016
- Quantity
- 3000 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fit Firm and Fabulous
Original FDA data
Every field from FDA enforcement report D-0722-2016, exactly as published.
Show all FDA fields
- City
- Mc Lean
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 72874
- Address
- 1504 Lincoln Way Apt 212
- Code information
- Lot #: 05/02/2015 to 05/01/2017
- Postal code
- 22102-5856
- Report date
- Feb 24, 2016
- Product type
- Drugs
- Recall number
- D-0722-2016
- Classification
- Class I
- Recalling firm
- Fit Firm and Fabulous
- Product quantity
- 3000 bottles
- Termination date
- Mar 16, 2016
- Reason for recall
- Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.
- Distribution pattern
- Nationwide in the U.S.A. via the website.
- Recall initiation date
- Sep 29, 2015
- Initial firm notification
- Visit
- Center classification date
- Feb 18, 2016