NDC 52565-094
Clobetasol Propionate (emollient) 0.5 mg per 1 g cream
On the label: Teligent Pharma, Inc..
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) 15377, Exp. 3/31/2022; 15927, Exp. 9/30/2022; 16130, Exp. 11/30/2022; b) 15117, Exp. 2/28/2022; 16028, Exp. 9/30/2022; 16945, Exp. 5/31/2023; c) 15377, Exp. 3/31/2022; 15927, Exp. 9/30/2022; 16683, Exp. 5/31/2022; d) 15116, Exp. 2/28/2022; 15117, Exp. 2/28/2022; 16130, Exp. 11/30/2022; 16…
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
- cream
- Strength
- 0.5 mg per 1 g
- Approval
- ANDA ANDA209411
- On the market since
- Aug 21, 2017
- Package NDCs
52565-094-1552565-094-3052565-094-4552565-094-60- Official label
- DailyMed (National Library of Medicine), updated Aug 21, 2017
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