The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1646-2012·Announced 2012-08-22

Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Scalp Oil

Hill Dermaceuticals is recalling 161,064 bottles of Derma-Smoothe/FS scalp oil because the product is subpotent, meaning it contains less of the active ingredient than labeled.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 III, which indicates a low probability of adverse health consequences. The hazard is a subpotent drug, which is a labeling/potency issue rather than a contamination or acute safety hazard.

Plain-English summary

Hill Dermaceuticals, Inc. is recalling 161,064 bottles of Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottles. The product is a prescription-only topical medication manufactured and distributed by Hill Dermaceuticals, Inc. in Sanford, Florida.

The recall was initiated because the product is subpotent, meaning it contains less of the active ingredient, fluocinolone acetonide, than stated on the label. The affected lots include H100084, H100086, J100093, J100094, J100097, K100101, K100103, K100104, K100108, K100112, L100860, L100890, and L100910, with expiration dates ranging from August 2012 to November 2012.

The product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.

The recalled product

Product
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
Manufacturer
Hill Dermaceuticals, Inc.
Category
Drug — Topical Steroid
Hazard
Affected units
161,064

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 (13)

  • 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).

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Hill Dermaceuticals, Inc. 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 2 products in this recall →

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