FDA recall D-1491-2014

Dermamedics, L.L.C. · Class II · 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.

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-1491-2014