Drug & medication recalls Moderate risk

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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