PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 24, 2018 Initiated: December 14, 2017 #D-0214-2018

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.

Details

Recalling Firm
SHISEIDO AMERICA INC.
Units Affected
248,661 bottle and /tubes
Distribution
Product was distributed nationwide.
Location
East Windsor, NJ

Frequently Asked Questions

What product 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. Recalled by SHISEIDO AMERICA INC.. Units affected: 248,661 bottle and /tubes.
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-0214-2018.