FDA recall D-1488-2014
Dermamedics, L.L.C. · Class II · drug
Product
Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.
Reason for recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2014-01-10
- Report date
- 2014-08-06
- Termination date
- 2017-03-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Oklahoma City, OK, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1488-2014