Salises Facial Moisturizing Acne Treatment Gel recalled over manufacturing violations

Recall date

October 15, 2015

Source

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

Official notice title

Sesderma, SL recalls Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Man…

Recall number

D-0843-2016

FDA classification

Class II

Brand / firm

Sesderma, SL

Sold / distributed

Distributed to following states: FL, PR, CO, GA.

Why it was recalled

cGMP Deviations; product does not comply with cGMP requirements

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

What was recalled

Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016