D-1493-2014 Class II Terminated
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