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
Reported: January 24, 2018 Initiated: December 14, 2017 #D-0215-2018
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.
Details
- Recalling Firm
- SHISEIDO AMERICA INC.
- Units Affected
- N/A
- Distribution
- Product was distributed nationwide.
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SHISEIDO AMERICA INC.. Units affected: N/A.
Why was this product recalled? ▼
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 24, 2018. Severity: Moderate. Recall number: D-0215-2018.
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