Recalls / Class II

Class IID-1492-2014

Product

Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019

Affected lot / code info

all lot codes

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-1492-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.