FDAFDA · Food and drugs·Recall number D-0215-2018
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
Published January 24, 2018 · Recall initiated: December 14, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SHISEIDO AMERICA INC.
- Distributor
- Product was distributed nationwide.
- Lot
- SKU#: a) 8C52541, b) 8B41841, c) 1155840, 1155841, 1155842, 1155851, 0710341, 0710342
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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