Home / Recalls / Dermamedics, L.L.C. / D-1489-2014

D-1489-2014 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
unknown

Product Description

Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008.

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

Other recalls by Dermamedics, L.L.C.

  • D-1491-2014 Class II — Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB1006 (January 10, 2014)
  • D-1494-2014 Class II — Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml co (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)