Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
Hill Dermaceuticals is recalling 8,734 bottles of Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.
What this means for you
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 risk of adverse health consequences. The hazard is a lack of efficacy (subpotency) rather than a direct safety threat like toxicity or contamination.
Plain-English summary
Hill Dermaceuticals, Inc. is recalling 8,734 bottles of Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil), 4 fl. oz., prescription only. The product was distributed nationwide and in Puerto Rico. The specific lot code is 13D010A with an expiration date of 10/14.
The recall was initiated because the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. This means the medication may not contain the full amount of the active ingredient required to be effective.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal. The product is identified by NDC 28105-150-04.
The recalled product
- Product
- Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04
- Manufacturer
- Hill Dermaceuticals, Inc.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 8,734
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 (1)
- 13D010A exp. 10/14.
Distribution
Part of a larger recall action
This product is one of 9 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 9 products in this recall →Related recalls
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