D-0214-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 24, 2018
- Initiation Date
- December 14, 2017
- Termination Date
- June 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