Drug 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
D-0214-2018
Product summary
- Event
- Event 78791
- Status
- Terminated
- Classification
- Class II
- Quantity
- 248,661 bottle and /tubes
- Official record key
drug-enforcement:D-0214-2018
Official wording
Reason: GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Code information: SKU#: BE8047201
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Manufacturing or process control
GMP Deviations