FDA recall D-1490-2014

Product

Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of DM 1011 and Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002.

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-1490-2014