FDAFDA · Food and drugs·Recall number D-1494-2014
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.
Published August 6, 2014 · Recall initiated: January 10, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dermamedics, L.L.C.
- Distributor
- Nationwide
- Lot
- all lot codes 30 ml and 50 ml
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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