Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.
Reported: February 24, 2016 Initiated: September 29, 2015 #D-0722-2016
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.
Details
- Recalling Firm
- Fit Firm and Fabulous
- Units Affected
- 3000 bottles
- Distribution
- Nationwide in the U.S.A. via the website.
- Location
- Mc Lean, VA
Frequently Asked Questions
What product was recalled? ▼
Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.. Recalled by Fit Firm and Fabulous. Units affected: 3000 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 24, 2016. Severity: Critical. Recall number: D-0722-2016.
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