Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
Hill Dermaceuticals is recalling 8,808 bottles of 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 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 8,808 bottles of Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil, 0.01%, 118.28 mL (4 Fl. oz.) bottles. The product is prescription-only and was distributed nationwide and in Puerto Rico. The specific lot number is H110940 with an expiration date of 08/13.
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 a lack of therapeutic effect for the patient.
Consumers with this product should contact their healthcare provider or pharmacist for guidance on how to proceed. The recall is classified as FDA Class III, 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) Topical Oil (SCALP OIL), 0.01 %, 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 Steroid
- Hazard
- Affected units
- 8,808
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 #: H110940
- Exp 08/13
Distribution
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