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) 15599, Exp. 4/30/2022; 16108, Exp. 10/31/2022; 16471, Exp. 2/28/2023; 16680, Exp. 3/31/2023; b) 15120, 15126, 15592, Exp. 2/28/2022; 15599, Exp. 4/30/2022; 16108, 16145, Exp. 10/31/2022; 16261, Exp. 12/31/2022; 16456, 16471, Exp. 2/28/2023; 16552, 16680, Exp. 3/31/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Clobetasol: every company that makes it
- Form
- lotion
- Strength
- .05 mg per 100 mL
- Approval
- ANDA ANDA208667
- On the market since
- Nov 29, 2016
- Package NDCs
52565-055-0252565-055-04- Official label
- DailyMed (National Library of Medicine), updated Nov 29, 2016
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