A1 Slim recalled over undeclared sibutramine

Recall date

October 6, 2017

Source

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

Official notice title

Kiriko, LLC. recalls A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SL…

Recall number

D-0058-2018

FDA classification

Class II

Brand / firm

Kiriko, LLC.

Sold / distributed

Nationwide.

Why it was recalled

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, info@a1slim.com Bar-Code A105212014