Drug 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
D-0215-2018
Product summary
- Event
- Event 78791
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0215-2018
Official wording
Reason: GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Code information: SKU#: a) 8C52541, b) 8B41841, c) 1155840, 1155841, 1155842, 1155851, 0710341, 0710342
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Manufacturing or process control
GMP Deviations