Home / Recalls / Dermamedics, L.L.C. / D-1494-2014

D-1494-2014 Class II Terminated

Recalled by Dermamedics, L.L.C. — Oklahoma City, OK

Recall Details

Product Type
Drugs
Report Date
August 6, 2014
Initiation Date
January 10, 2014
Termination Date
March 14, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

all lot codes 30 ml and 50 ml

Other recalls by Dermamedics, L.L.C.

  • D-1489-2014 Class II — Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU n (January 10, 2014)
  • D-1491-2014 Class II — Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB1006 (January 10, 2014)
  • D-1490-2014 Class II — Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed (January 10, 2014)
  • D-1495-2014 Class II — Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml co (January 10, 2014)
  • D-1492-2014 Class II — Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser (January 10, 2014)
  • D-1493-2014 Class II — Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medi (January 10, 2014)
  • D-1488-2014 Class II — Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020. (January 10, 2014)
  • D-1487-2014 Class II — Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with (January 10, 2014)