FDA recall D-0214-2018

Product

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.

Distribution

Product was distributed nationwide.

Key facts

Status

Terminated

Initiation date

2017-12-14

Report date

2018-01-24

Termination date

2021-06-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0214-2018