Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Body Oil
Hill Dermaceuticals is recalling 111,816 bottles of Derma-Smoothe/FS Body 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Hill Dermaceuticals, Inc. is recalling 111,816 bottles of Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. The recall is due to the product being subpotent, which means it contains less of the active ingredient, fluocinolone acetonide, than stated on the label.
The affected product is a prescription-only topical body oil manufactured and distributed by Hill Dermaceuticals, Inc. in Sanford, Florida. The recall covers specific lot numbers: J100095, J100099, K100106, K100111, L100872, L100880, and D110560. The distribution pattern is nationwide.
Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled lots. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04
- Manufacturer
- Hill Dermaceuticals, Inc.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 111,816
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 (7)
- Lot Numbers: -Body Oil: J100095 (exp 09/12)
- J100099 (exp 09/12)
- K100106 (exp 10/12)
- K100111 (exp 10/12)
- L100872 (exp 11/12)
- L100880 (exp 11/12)
- D110560 (exp 04/13).
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 →Related recalls
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