FDA Recalls Unapproved Dermamedics and Therametics Baby's Relief Creams
Dermamedics, L.L.C. is recalling specific lots of Dermamedics and Therametics Baby's Relief Calm and Repair Cream because the products are unapproved new drugs and misbranded.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Dermamedics, L.L.C. is recalling Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers (SKU DM1016) and 0.25 oz. containers (SKU PS 1016), as well as Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers (SKU BR008). The recall covers all lot codes for these specific products.
The U.S. Food and Drug Administration (FDA) determined that these products are unapproved new drugs and misbranded because they were marketed without an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The products were distributed nationwide.
Consumers who have these products should stop using them and contact Dermamedics, L.L.C. for further instructions. The FDA classifies this recall as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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.
- Manufacturer
- Dermamedics, L.L.C.
- Category
- Drug — Topical Cream
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Dermamedics, L.L.C. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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