ULTRA ZX DIETARY SUPPLEMENT recalled over undeclared sibutramine

Recall date

March 10, 2015

Source

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

Official notice title

Ultra ZX Supplements recalls ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almido…

Recall number

D-0991-2015

FDA classification

Class I

Brand / firm

Ultra ZX Supplements

Sold / distributed

Nationwide and Puerto Rico Foreign: Spain and Ecuador

Why it was recalled

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX 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

ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068.