Dermamedics Calm and Correct Cream Recalled for Lack of FDA Approval
Dermamedics, L.L.C. is recalling Calm and Correct Cream because the FDA determined the product is an unapproved new drug 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 level where the use of the product may cause temporary or medically reversible health consequences. The source text does not report any specific injuries or illnesses.
Plain-English summary
Dermamedics, L.L.C. is recalling Dermamedics Calm and Correct Cream 2 oz. containers, which are included in the Dermamedics Post Medical Procedure Kit with SKU number SK1005. The recall covers all lot codes and the product was distributed nationwide.
The FDA determined that the product is an unapproved new drug and misbranded because it was marketed without an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). No specific illnesses or injuries are reported in the source text.
Consumers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005
- Manufacturer
- Dermamedics, L.L.C.
- Category
- Drug — Topical Dermatology
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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