NDC 52565-042
Nystatin and Triamcinolone Acetonide 1 mg per 1 g / 100000 [USP'U] per 1 g ointment
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) 15125, Exp. 2/28/2022; 15385, Exp. 3/31/2022; 15613, Exp. 5/31/2022; 16027, Exp. 9/30/2022; 16204, Exp. 11/30/2022; 16376, Exp. 1/31/2023; 16707, Exp. 3/31/2023; b) 15385, Exp. 3/31/2022; 15752, Exp. 6/30/2022; 15346, Exp. 9/30/2022; 16188, Exp. 11/30/2022; 16567, Exp. 2/28/2023; 16730, E…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Nystatin and Triamcinolone Acetonide: every company that makes it
- Form
- ointment
- Strength
- 1 mg per 1 g / 100000 [USP'U] per 1 g
- Approval
- ANDA ANDA208287
- On the market since
- Dec 30, 2016
- Package NDCs
52565-042-1552565-042-3052565-042-60- Official label
- DailyMed (National Library of Medicine), updated Dec 30, 2016
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