Hill Dermaceuticals Recalls Subpotent Dermotic Ear Drops
Hill Dermaceuticals is recalling Dermotic ear drops 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 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 contamination.
Plain-English summary
Hill Dermaceuticals, Inc. is recalling 13,379 bottles of Dermotic (fluocinolone acetonide) 0.01% ear drops. The product is a prescription-only medication manufactured for Royal Pharmaceuticals. The recall covers bottles with lot codes 13F015B (expiration 12/14) and 13G023B (expiration 01/15).
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.
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 for further instructions.
The recalled product
- Product
- DERMOTIC (FLUOCINOLONE ACETONIDE)
- Brand
- DERMOTIC
- Manufacturer
- Hill Dermaceuticals, Inc.
- Hazard
- Affected units
- 13,379
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)
- 13F015B exp. 12/14
- 13G023B exp. 01/15
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
Same brand · DERMOTIC
- HighDermOtic fluocinolone acetonide ear drops recalled for broken glass risk
FDA (Drugs) · 2021-06-30
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