US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 14, 2017 (9 years ago)

Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

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

Recalling firm
Shiseido America INC.
NDC code
58411-256-60
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0215-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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