D-0216-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 24, 2018
- Initiation Date
- December 14, 2017
- Termination Date
- June 24, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Distribution Pattern
Product was distributed nationwide.
Code Information
SKU#: 95167