Recalls / Class II
Class IID-1488-2014
Product
Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.
- Affected lot / code info
- all lot codes, .25 oz and 2 oz sizes
Why it was recalled
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Recalling firm
- Firm
- Dermamedics, L.L.C.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Research Pkwy Ste 150, Oklahoma City, Oklahoma 73104-3621
Distribution
- Quantity
- unknown
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-01-10
- FDA classified
- 2014-07-29
- Posted by FDA
- 2014-08-06
- Terminated
- 2017-03-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1488-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.