The Recall Desk
ModerateFDA (Drugs)·D-1487-2014·Announced 2014-08-06

Dermamedics Post Procedure Cream Recalled for Lack of FDA Approval

Dermamedics, L.L.C. is recalling Post Procedure 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 (2) in the absence of reported injuries or specific high-risk pathogens.

Plain-English summary

Dermamedics, L.L.C. is recalling Dermamedics Post Procedure Cream, 1 ounce containers distributed with SKU number DM 1026. The recall covers all lot codes and the product was distributed nationwide.

The FDA has 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). This classification indicates the product did not meet the regulatory requirements for safety and efficacy before being sold to consumers.

Consumers who have this product should stop using it and contact Dermamedics, L.L.C. for further instructions or a refund. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026

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 →