Drug product
Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.
D-0722-2016
Product summary
- Event
- Event 72874
- Status
- Terminated
- Classification
- Class I
- Quantity
- 3000 bottles
- Official record key
drug-enforcement:D-0722-2016
Official wording
Reason: 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.
Code information: Lot #: 05/02/2015 to 05/01/2017
Distribution pattern: Nationwide in the U.S.A. via the website.
Derived failure modes
-
Unknown
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.