SHISEIDO AMERICA INC. recalls Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide
Recalled January 24, 2018 · FDA recall D-0215-2018 · SHISEIDO AMERICA
Hazard
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. · FDA Class II
Units
N/A
Sold at
Product was distributed nationwide.
Description
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Product
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
Manufacturer(s)
SHISEIDO AMERICA INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →