Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenz...
FDA Recall #D-0215-2018 — Class II — December 14, 2017
Product Description
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
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#: a) 8C52541, b) 8B41841, c) 1155840, 1155841, 1155842, 1155851, 0710341, 0710342
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated