Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: -Scalp Oil: H100084 (exp 08/12), H100086 (08/12), J100093 (exp 08/12), J100094 (exp 09/12), J100097 (exp 09/12), K100101 (exp 09/12), K100103 (exp 10/12), K100104 (exp 10/12), K100108 (exp 10/12), K100112 (exp 10/12), L100860 (exp 11/12), L100890 (exp 11/12), L100910 (exp 11/12).
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Hill Dermaceuticals, Inc.
Reason for Recall:
Subpotent; fluocinolone acetonide
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04

Product Codes/Lot Numbers:

Lot Numbers: -Scalp Oil: H100084 (exp 08/12), H100086 (08/12), J100093 (exp 08/12), J100094 (exp 09/12), J100097 (exp 09/12), K100101 (exp 09/12), K100103 (exp 10/12), K100104 (exp 10/12), K100108 (exp 10/12), K100112 (exp 10/12), L100860 (exp 11/12), L100890 (exp 11/12), L100910 (exp 11/12).

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1646-2012

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