Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Teligent Pharma, Inc. | Buena, New Jersey, United States | Makes it | Serious problems, FDA actionAug 31, 2021 · 8 inspections, 1 with FDA action |
Recalls
- Mar 15, 2022 · Class II · Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Lots: Batch: 17138, Exp. 2/28/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fluocinonide: every company that makes it
- Form
- solution
- Strength
- 0.5 mg per 1 mL
- Approval
- ANDA ANDA207554
- On the market since
- Mar 18, 2019
- Package NDCs
52565-025-2052565-025-59- Official label
- DailyMed (National Library of Medicine), updated Aug 24, 2016
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