Drug product
Shiseido Future Solutions LX Triple Points Bonus 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, NDC 58411-256-60
D-0218-2018
Product summary
- Event
- Event 78791
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0218-2018
Official wording
Reason: GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Code information: SKU#: 95284
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Manufacturing or process control
GMP Deviations