Recalls / Class II
Class IID-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
- Affected lot / code info
- SKU#: a) 8C52541, b) 8B41841, c) 1155840, 1155841, 1155842, 1155851, 0710341, 0710342
Why it was recalled
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Recalling firm
- Firm
- SHISEIDO AMERICA INC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 366 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1411
Distribution
- Quantity
- N/A
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2017-12-14
- FDA classified
- 2018-01-12
- Posted by FDA
- 2018-01-24
- Terminated
- 2021-06-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0215-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.