Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
Hill Dermaceuticals is recalling Derma-Smoothe/FS topical oil because routine testing found the active ingredient to be subpotent.
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 recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences, and no injuries or illnesses are reported in the source text.
Plain-English summary
Hill Dermaceuticals, Inc. is recalling Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottles. The product is prescription-only and was manufactured and distributed by Hill Dermaceuticals, Inc. in Sanford, Florida.
The recall was initiated because the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. The affected lots are K111100 (exp. 10/13), K111110 (exp. 10/13), M111240 (exp. 12/13), and A120012 (exp. 01/14). The product was distributed nationwide and in Puerto Rico.
Consumers with this product should contact their healthcare provider or pharmacist for guidance on how to proceed.
The recalled product
- Product
- Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04.
- Manufacturer
- Hill Dermaceuticals, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
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 (4)
- K111100 exp.10/13
- K111110 exp.10/13
- M111240 exp.12/13
- and A120012 exp.01/14
Distribution
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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