D-1493-2014 Class II Terminated

Recalled by Dermamedics, L.L.C. — Oklahoma City, OK

Recall Details

Product Type
Drugs
Report Date
August 6, 2014
Initiation Date
January 10, 2014
Termination Date
March 14, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005

Reason for Recall

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Distribution Pattern

Nationwide

Code Information

all lot codes