Dermamedics Calm & Correct Cream Recalled for Lack of FDA Approval
Dermamedics, L.L.C. is recalling Calm & 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 score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Dermamedics, L.L.C. is recalling Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020. The recall includes all lot codes and both .25 oz and 2 oz sizes. The product was distributed nationwide.
The FDA determined that the products are unapproved new drugs and misbranded because they were marketed without an Approved NDA/ANDA. No specific injuries or illnesses were reported in the source text.
Consumers should stop using the recalled product. The recalling firm, Dermamedics, L.L.C., is responsible for the recall.
The recalled product
- Product
- Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.
- 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 (2)
- all lot codes
- .25 oz and 2 oz sizes
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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