SHISEIDO AMERICA INC. recalls bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bott…
- Recall date
- December 14, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0214-2018
- FDA classification
- Class II
- Brand / firm
- SHISEIDO AMERICA INC.
- Sold / distributed
- Product was distributed nationwide.
Why it was recalled
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01
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