Dermamedics Serum Recalled for Lacking FDA Approval
Dermamedics, L.L.C. is recalling Calm and Correct Serum because 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, or where the probability of serious adverse health consequences is remote.
Plain-English summary
Dermamedics, L.L.C. is recalling Dermamedics Calm and Correct Serum in 2 oz. containers (SKU BB10062) and 4 oz. containers (SKU BB10068). The recall covers all lot codes and the product was distributed nationwide.
The U.S. Food and Drug Administration determined that the products are unapproved new drugs and misbranded because they were marketed without an Approved NDA/ANDA. The source text does not report any specific illnesses or injuries associated with the product.
Consumers should stop using the product and contact the recalling firm for instructions on how to return it or obtain a refund.
The recalled product
- Product
- Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068.
- 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.
See all 9 products in this recall →Related recalls
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