PlainRecalls
FDA Drug Moderate Class II Terminated

Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022,

Reported: January 24, 2018 Initiated: December 14, 2017 #D-0216-2018

Product Description

Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022,

Reason for Recall

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

Details

Recalling Firm
SHISEIDO AMERICA INC.
Units Affected
N/A
Distribution
Product was distributed nationwide.
Location
East Windsor, NJ

Frequently Asked Questions

What product was recalled?
Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022,. Recalled by SHISEIDO AMERICA INC.. Units affected: N/A.
Why was this product recalled?
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 24, 2018. Severity: Moderate. Recall number: D-0216-2018.