Pink Bikini capsules recalled over undeclared sibutramine

Recall date

December 9, 2015

Source

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

Official notice title

Lucy's Weight Loss (dba. Waisted With Lucy) recalls Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Luc…

Recall number

D-0882-2016

FDA classification

Class I

Brand / firm

Lucy's Weight Loss (dba. Waisted With Lucy)

Sold / distributed

Nationwide

Why it was recalled

Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.

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

Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010