Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, oct...
FDA Recall #D-0217-2018 — Class II — December 14, 2017
Product Description
Shiseido Future Solution LX Luxurious Eye & Lip Collection 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.
Recalling Firm
SHISEIDO AMERICA INC. — East Windsor, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Product was distributed nationwide.
Code Information
SKU#: 95393
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated