FDA Recall D-0722-2016
Fit Firm and Fabulous · Mc Lean, VA
Class I — life-threatening Terminated 169 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.
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.
Recall record
- Recall number
D-0722-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Visit
- Distribution
- Nationwide in the U.S.A. via the website.
- Recall initiated
- 2015-09-29
- Classified by FDA Center
- 2016-02-18
- FDA published
- 2016-02-24
- Terminated
- 2016-03-16
- Recalling firm
- Fit Firm and Fabulous
- Firm location
- Mc Lean, VA