NDC 64980-329
Fluocinolone AcetonideOil 0.11 mg per 1 mL oil
On the label: Rising Pharma Holdings, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lyne Laboratories, Inc. | Brockton, MA, United States | Makes it | Problems found, fixed voluntarilyMar 10, 2026 · 9 inspections, 1 with FDA action |
Recalls
- Apr 13, 2018 · Class II · Lyne Laboratories, Inc.
Subpotent Drug
Lots: Lot#: FR1604B, FR1604C, FR 1604D, Exp. 06/2018
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
- ANDA ANDA203378
- On the market since
- Sep 14, 2016
- Package NDCs
64980-329-20- Official label
- DailyMed (National Library of Medicine), updated Mar 9, 2026
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