D-0722-2016 Class I Terminated
FDA drug recall D-0722-2016 was initiated by Fit Firm and Fabulous on September 29, 2015 and is designated Class I. 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 th… The recall status is terminated (terminated March 16, 2016). Affected quantity: 3000 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 24, 2016
- Initiation Date
- September 29, 2015
- Termination Date
- March 16, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3000 bottles
Product Description
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.
Distribution Pattern
Nationwide in the U.S.A. via the website.
Code Information
Lot #: 05/02/2015 to 05/01/2017