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) 15856, Exp. 8/31/2022; 17026, Exp. 6/30/2023; b) 15856, Exp. 8/31/2022; 17026, Exp. 6/30/2023; 17046, Exp. 6/30/2023; c) 15856, Exp. 8/31/2022; d) 15856, Exp. 8/31/2022; 17026, Exp. 6/30/2023 - Nov 5, 2020 · Class III · Teligent Pharma, Inc.
Superpotent and Subpotent; low and high assay results
Lots: Lot Number: 12597, exp. date 12/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Clobetasol: every company that makes it
- Form
- ointment
- Strength
- 0.5 mg per 1 g
- Approval
- ANDA ANDA208589
- On the market since
- Jan 23, 2019
- Package NDCs
52565-039-1552565-039-3052565-039-4552565-039-60- Official label
- DailyMed (National Library of Medicine), updated Jan 23, 2019
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