D-0215-2018 Class II Terminated
FDA drug recall D-0215-2018 was initiated by SHISEIDO AMERICA INC. on Dec 14, 2017 and is designated Class II. Reason for recall: GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. The recall status is terminated (terminated Jun 24, 2021).
Recall details
- Product Type
- Drugs
- Report Date
- Jan 24, 2018
- Initiation Date
- Dec 14, 2017
- Termination Date
- Jun 24, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
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.
Distribution pattern
Product was distributed nationwide.
Code information
SKU#: a) 8C52541, b) 8B41841, c) 1155840, 1155841, 1155842, 1155851, 0710341, 0710342
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0215-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026