Ultimate Herbal Slimcap Capsules recalled over undeclared sibutramine

Recall date

September 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Fit Firm and Fabulous recalls Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 2542…

Recall number

D-0722-2016

FDA classification

Class I

Brand / firm

Fit Firm and Fabulous

Sold / distributed

Nationwide in the U.S.A. via the website.

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.