D-1490-2014 Class II Terminated
FDA drug recall D-1490-2014 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). Affected quantity: unknown.
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
- unknown
Product Description
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 Pattern
Nationwide
Code Information
all lot codes