Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hill Dermaceuticals, Inc. | Sanford, FL, United States | Makes it | Problems found, fixed voluntarilyOct 14, 2025 · 9 inspections, 4 with FDA action |
Recalls
- Jan 31, 2014 · Class III · Hill Dermaceuticals, Inc.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Lots: 13E013A exp. 11/14.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fluocinolone Acetonide: every company that makes it
- Form
- oil, topical
- Strength
- 0.11 mg per 1 mL
- Approval
- NDA NDA019452
- On the market since
- Feb 16, 1995
- Package NDCs
68791-101-0168791-101-04- Official label
- DailyMed (National Library of Medicine), updated Oct 27, 2026
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