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: 15066, 15389 Exp. 3/31/2023; 15437, Exp. 12/31/2023; 16823, Exp. 4/30/2024; 16825, 16826, Exp. 4/30/2024 - Oct 19, 2021 · Class II · Teligent Pharma, Inc.
Defective Container
Lots: Lot #: 15188, Exp 2/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Diclofenac: every company that makes it
- Form
- solution
- Strength
- 16.05 mg per 1 mL
- Approval
- ANDA ANDA202769
- On the market since
- Jul 31, 2018
- Package NDCs
52565-002-0552565-002-59- Official label
- DailyMed (National Library of Medicine), updated Nov 6, 2018
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