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
- May 21, 2021 · Class II · Hill Dermaceuticals, Inc.
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Lots: Lot #: 19K036D, 19L039E Exp. 05/21; 20A001E, 20A003D, 20A003E, Exp. 07/21; 20C013G Exp. 09/21; 20E025F, 20E025G, 20E025H Exp. 12/21; 20H041D, 20H041F Exp. 02/22; 20J043E Exp. 03/22; 20K050F Exp. 04/22; 20L055E Exp. 06/22; 21C015E, 21C018E Exp. 09/22 - 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: 13F015B exp. 12/14, 13G023B exp. 01/15
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, auricular (otic)
- Strength
- 0.11 mg per 1 mL
- Approval
- NDA NDA019452
- On the market since
- Nov 9, 2005
- Package NDCs
68791-103-20- Official label
- DailyMed (National Library of Medicine), updated May 9, 2025
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