drugs Class II Updated 2014-08-06

Dermamedics, L.L.C. recalls Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. con

Recalled Product

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.

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
View official government recall

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