SHISEIDO AMERICA INC. recalls Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxid…

Recall date

December 14, 2017

Source

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

Recall number

D-0215-2018

FDA classification

Class II

Brand / firm

SHISEIDO AMERICA INC.

Sold / distributed

Product was distributed nationwide.

Why it was recalled

GMP Deviations: manufacturing of API material did not meet GMP and quality 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

Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, b) 15 mL and c) 50 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022. NDC 58411-256-60