FDA recall D-1489-2014

Dermamedics, L.L.C. · Class II · 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.

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-1489-2014