Drug product
Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068.
D-1491-2014
Product summary
- Event
- Event 67247
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-1491-2014
Official wording
Reason: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Code information: all lot codes
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
misbranded