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) 15000, Exp. 1/31/2023; 15591, Exp. 4/30/2023; 15946, Exp. 9/30/2023; b) 14674, Exp. 11/30/2022; 14760, 14798, Exp. 12/31/2022; 14896, Exp. 1/31/2023; 15000, Exp. 1/31/2023; 15591, Exp. 4/30/2023; 15802, 15833, Exp. 7/31/2023; 15872, Exp. 8/31/2023; 15946, Exp. 9/30/2023; 16069, Exp. 10/31… - Jul 19, 2021 · Class II · Teligent Pharma, Inc.
Correct Labeled Product Mispack
Lots: Lot # 16630; Exp 03/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Triamcinolone Acetonide: every company that makes it
- Form
- ointment
- Strength
- 1 mg per 1 g
- Approval
- ANDA ANDA205373
- On the market since
- May 13, 2016
- Package NDCs
52565-014-1552565-014-2652565-014-80- Official label
- DailyMed (National Library of Medicine), updated May 13, 2016
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