Drug 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.
D-0065-2019
Product summary
- Event
- Event 80750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,480 tubes
- Official record key
drug-enforcement:D-0065-2019
Official wording
Reason: Failed Stability Specifications: separation of product and failure for actives.
Code information: Lot: 161223D, Exp. 4/16/2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications