drugs Class II Updated 2014-08-06

Dermamedics, L.L.C. recalls Dermamedics Complexion Repair Topical Rehydrating Emulsion i

Recalled 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.

Hazard / Issue

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: all lot codes 30 ml and 50 ml
View official government recall

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