Why it was recalled
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
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
Lot numbers, UPCs & expiration codes
SKU#: BE8047201
Where it was sold
Product was distributed nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0214-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 14, 2017
- FDA report date
- Jan 24, 2018
- Quantity
- 248,661 bottle and /tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SHISEIDO AMERICA INC.
Original FDA data
Every field from FDA enforcement report D-0214-2018, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78791
- Address
- 366 Princeton Hightstown Rd
- Code information
- SKU#: BE8047201
- Postal code
- 08520-1411
- Report date
- Jan 24, 2018
- Product type
- Drugs
- Recall number
- D-0214-2018
- Classification
- Class II
- Recalling firm
- SHISEIDO AMERICA INC.
- Product quantity
- 248,661 bottle and /tubes
- Termination date
- Jun 24, 2021
- Reason for recall
- GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed nationwide.
- Recall initiation date
- Dec 14, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 12, 2018