Recalls / Class II
Class IID-1495-2014
Product
Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Complexion Repair Acne Treatment System Kit and the Complexion Repair Acne Travel Kit with SKU numbers of CR1005 and CR1007, respectively.
- Affected lot / code info
- all lot codes 30 ml and 50 ml
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
- 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-1495-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.