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) 15280, Exp. 2/28/2022; 16539, Exp. 3/31/2023; 16907, Exp. 5/31/2023; b) 15381, Exp. 3/31/2022; 15382, 15501, 15523, Exp. 4/30/2022; 15812, Exp. 7/31/2022; 15972, 16034, 16037, Exp. 9/30/2022; 16105, 16143, Exp. 10/31/2022; 16539, 16746, 16747, Exp. 3/31/2023; 16906, Exp. 5/31/2023; 16962,…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Halobetasol: every company that makes it
- Form
- ointment
- Strength
- 0.5 mg per 1 g
- Approval
- ANDA ANDA209978
- On the market since
- Mar 20, 2018
- Package NDCs
52565-073-1552565-073-51- Official label
- DailyMed (National Library of Medicine), updated Mar 20, 2018
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