FDAClass IIAugust 6, 2014

Dermamedics Baby's Relief Calm and Repair Cream in recall

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…

Why was Dermamedics Baby's Relief Calm and Repair Cream in recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

all lot codes

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…
Recalling firm
Dermamedics, L.L.C.
Quantity
unknown
Distribution
Nationwide
Recall date
August 6, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls