D-1491-2014 Class II Terminated
FDA drug recall D-1491-2014 was initiated by Dermamedics, L.L.C. on January 10, 2014 and is designated Class II. Reason for recall: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. The recall status is terminated (terminated March 14, 2017).
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 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 Pattern
Nationwide
Code Information
all lot codes