Recalls / Class II
Class IID-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
- Affected lot / code info
- SKU#: BE8047201
Why it was recalled
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Recalling firm
- Firm
- SHISEIDO AMERICA INC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 366 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1411
Distribution
- Quantity
- 248,661 bottle and /tubes
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2017-12-14
- FDA classified
- 2018-01-12
- Posted by FDA
- 2018-01-24
- Terminated
- 2021-06-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0214-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.