D-0214-2018 Class II Terminated
FDA drug recall D-0214-2018 was initiated by SHISEIDO AMERICA INC. on Dec 14, 2017 and is designated Class II. Reason for recall: GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. The recall status is terminated (terminated Jun 24, 2021). Affected quantity: 248,661 bottle and /tubes.
Recall details
- Product Type
- Drugs
- Report Date
- Jan 24, 2018
- Initiation Date
- Dec 14, 2017
- Termination Date
- Jun 24, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 248,661 bottle and /tubes
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.
Distribution pattern
Product was distributed nationwide.
Code information
SKU#: BE8047201
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0214-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026