FDA recall D-0215-2018

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

Reason for recall

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

Distribution

Product was distributed nationwide.

Key facts

Status

Terminated

Initiation date

2017-12-14

Report date

2018-01-24

Termination date

2021-06-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0215-2018