Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
Hill Dermaceuticals is recalling 7,676 bottles of 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 the rubric indicates is typically a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is a lack of efficacy rather than direct toxicity.
Plain-English summary
Hill Dermaceuticals, Inc. is recalling 7,676 bottles of Seton Pharmaceuticals Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., prescription only. The product is identified by NDC 13925-506-04 and lot code 13F016A with an expiration date of 12/14.
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 than the labeled amount of the active ingredient, which may result in the medication being less effective than intended.
The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04
- Manufacturer
- Hill Dermaceuticals, Inc.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 7,676
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)
- 13F016A exp. 12/14.
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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