Pink Bikini Strong Formula capsules recalled over undeclared sibutramine

Recall date

September 23, 2015

Source

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

Official notice title

Lucy's Weight Loss (dba. Waisted With Lucy) recalls Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy…

Recall number

D-0879-2016

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 and phenolphthalein.

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 Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010