Drug product
Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008.
D-1489-2014
Product summary
- Event
- Event 67247
- Status
- Terminated
- Classification
- Class II
- Quantity
- unknown
- Official record key
drug-enforcement:D-1489-2014
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