bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 4...
FDA Recall #D-0214-2018 — Class II — December 14, 2017
Product Description
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
Reason for Recall
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Recalling Firm
SHISEIDO AMERICA INC. — East Windsor, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
248,661 bottle and /tubes
Distribution
Product was distributed nationwide.
Code Information
SKU#: BE8047201
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated