Recalls / Class II

Class IID-1494-2014

Product

Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Dermamedics Complexion Repair Acne Treatment System Kit with SKU numbers of DM 1013 and DM 1025, respectively; Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002 and in 50 ml containers in the Therametics Complexion Repair Acne Treatment System Kit with a SKU number of CR1005; and in 30 ml containers in the Therametics Complexion Repair Acne Travel Kit with a SKU number of CR1007.

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-1494-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.