Recalls / Class II
Class IID-0065-2019
Product
dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distributed by: Cosmetic Dermatology, Inc., Miami, FL 33172, UPC 6 63963 00828 7.
- Affected lot / code info
- Lot: 161223D, Exp. 4/16/2019
Why it was recalled
Failed Stability Specifications: separation of product and failure for actives.
Recalling firm
- Firm
- Product Quest Manufacturing LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 330 Carswell Ave, N/A, Daytona Beach, Florida 32117-4416
Distribution
- Quantity
- 9,480 tubes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-08-03
- FDA classified
- 2018-10-16
- Posted by FDA
- 2018-10-24
- Terminated
- 2021-03-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0065-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.