NDC 0078-0911
Xiidra 50 mg per 1 mL solution/ drops
On the label: Novartis Pharmaceuticals Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| The Ritedose Corporation | Columbia, SC, United States | Makes it | Problems found, fixed voluntarilyFeb 28, 2025 · 12 inspections |
Recalls
- May 10, 2022 · Class III · Novartis Pharmaceuticals Corporation
Failed Impurities/Degradation Specifications.
Lots: Lot #:a) and b) 20E21, 20E22, 20E53, 20E54, 20E95, 20E96, 20ED1, 20ED2, 20ED3, 20EK1 Exp. Date 4/2023; 20F27, 20F28, 20F66, 20F67,20FH6, Exp. Date 05/2023; 20G47, 20G48, 20G49, 20G57, 20GB8, 20GE5, 20GE6, Exp. Date 06/2023; 20M41, 20M42, 20M56, 20M66, 20M67, 20MA4, Exp. Date 07/2023; 20S20, 20S22… - May 10, 2022 · Class III · Novartis Pharmaceuticals Corporation
Failed Impurities/Degradation Specifications.
Lots: Lot #: a) and b) 20DJ3, Exp. Date 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
- Lifitegrast: every company that makes it
- Form
- solution/ drops, ophthalmic
- Strength
- 50 mg per 1 mL
- Approval
- NDA NDA208073
- On the market since
- Jul 11, 2016
- Package NDCs
0078-0911-050078-0911-120078-0911-940078-0911-95- Official label
- DailyMed (National Library of Medicine), updated Aug 18, 2025
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