Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
Hill Dermaceuticals is recalling 8,736 bottles of Derma-Smoothe/FS topical oil because the product was found to be subpotent at the 12-month stability timepoint.
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 by definition indicates that use of or exposure to the product is not likely to cause adverse health consequences. The hazard is a lack of efficacy (subpotency) rather than a direct safety risk like toxicity or infection.
Plain-English summary
Hill Dermaceuticals, Inc. is recalling 8,736 bottles of Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil. The product is a prescription-only body oil distributed nationwide. The recall involves Lot J111040 with an expiration date of 09/13.
The recall was initiated because the product was found to be subpotent at the 12-month stability timepoint. This means the medication may not contain the full intended amount of the active ingredient, potentially reducing its therapeutic effectiveness.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for guidance. The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04
- Manufacturer
- Hill Dermaceuticals, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 8,736
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 (2)
- Lot J111040
- Exp. (09/13)
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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