Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
Hill Dermaceuticals is recalling specific lots of Derma-Smoothe/FS topical oil because routine testing found the active ingredient to be subpotent.
What this means for you
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 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 Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl. oz.) bottles. The recall involves specific lots with expiration dates ranging from October 2013 to December 2013. The product is prescription-only and was distributed nationwide and in Puerto Rico.
The recall was initiated because the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. Subpotent drugs contain less of the active ingredient than labeled, which may result in the product being less effective than intended.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-149-04.
- 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 (9)
- K111090 exp.10/13
- K111122 exp10/13
- K111140 exp.10/13
- K111150 exp.10/13
- 111180 exp.11/13
- L111190 exp11/13
- M111250 exp.12/13
- M111270 exp.12/13
- and M111292 exp.12/13
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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- LowHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
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- ModerateHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
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- ModerateHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
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