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: 14796, Exp. 12/31/2022; 14797, Exp. 1/31/2023; 14534, 15571, 15572, Exp. 4/30/2023; 15746, 15756, Exp. 6/30/2023; 15982, Exp. 9/30/2023; 16043, 16144, 16149, Exp. 10/31/2023; 16433, 16434, Exp. 2/29/2024; 16656, 16679, Exp. 3/31/2024; 16784, Exp. 5/31/2024 - Nov 3, 2020 · Class III · Teligent Pharma, Inc.
Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
Lots: Lot #: 14481 Exp 10/31/2021
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
- lotion
- Strength
- 0.25 mg per 1 mL
- Approval
- ANDA ANDA204608
- On the market since
- Jul 8, 2016
- Package NDCs
52565-010-59- Official label
- DailyMed (National Library of Medicine), updated Apr 27, 2015
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