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) 15495, Exp. 4/30/2022; 16955, Exp. 5/31/2023; b) 15249, 15250, 15446, Exp. 3/31/2022; 15495, Exp. 4/30/2022; 16377, Exp. 1/31/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Desonide: every company that makes it
- Form
- ointment
- Strength
- 0.5 mg per 1 g
- Approval
- ANDA ANDA212002
- On the market since
- Mar 13, 2019
- Package NDCs
52565-038-1552565-038-60- Official label
- DailyMed (National Library of Medicine), updated Mar 13, 2019
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