Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Scalp Oil
Hill Dermaceuticals is recalling 7,292 bottles of Derma-Smoothe/FS scalp oil because the active ingredient was found to be subpotent during routine testing.
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 FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a subpotent drug, which is a quality issue rather than a direct safety threat like contamination or injury.
Plain-English summary
Hill Dermaceuticals, Inc. is recalling 7,292 bottles of Derma-Smoothe/FS (fluocinolone acetonide 0.01% Scalp Oil), 4 fl. oz., NDC 68791-102-04. The product was manufactured by Hill Dermaceuticals for Royal Pharmaceuticals and 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. The affected lots are identified by the codes 13E014A (expiration 11/14) and 13F02C (expiration 12/14).
Consumers should stop using the product and return it to the pharmacy or point of purchase for a refund or replacement. This is a prescription-only medication.
The recalled product
- Product
- DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE)
- Brand
- DERMA-SMOOTHE/FS
- Manufacturer
- Hill Dermaceuticals, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 7,292
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)
- 13E014A exp. 11/14
- 13F02C 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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