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: a) 15196, Exp. 2/28/2022; 16605, Exp. 3/31/2023; b)15190, Exp. 2/28/2022; 16660, Exp. 4/30/2023; 17037, Exp. 6/30/2023; 17163, Exp. 8/31/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Desoximetasone: every company that makes it
- Form
- ointment
- Strength
- 0.5 mg per 1 g
- Approval
- ANDA ANDA209973
- On the market since
- Oct 23, 2018
- Package NDCs
52565-045-1552565-045-3052565-045-6052565-045-99- Official label
- DailyMed (National Library of Medicine), updated Oct 23, 2018
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