Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Farmabios S.p.A. | Gropello Cairoli, Italy | Makes the active ingredient | Problems found, fixed voluntarilyOct 1, 2021 · 6 inspections |
| Indoco Remedies Limited | Goa, India | Makes it | Serious problems, FDA actionFeb 28, 2023 · 6 inspections, 3 with FDA action |
Recalls
- Aug 22, 2022 · Class II · Cipla
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Lots: Lot #: DEG1HC2, DEG2HC2, DEG3HC2, DEG4HC2, DEG5HC2, DEG6HC2, Exp 01/2023; DEG1IC2, DEG2IC2, DEG3IC2, DEG4IC2, Exp 02/2023; DEG1LC2, DEG2LC2, Exp 05/2023; DEG1BD2, DEG2BD2, DEG3BD2, Exp 07/2023 - Aug 2, 2022 · Class II · Cipla
Lack of Assurance of Sterility: Complaints received of defective container closure.
Lots: Lot # DEG3LC2, Exp 05/2023 - Jul 14, 2022 · Class II · Cipla
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Lots: Batch# DEG4LC2, exp. date 05/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Difluprednate: every company that makes it
- Form
- emulsion, ophthalmic
- Strength
- 0.5 mg per 1 mL
- Approval
- ANDA ANDA211776
- On the market since
- Aug 9, 2021
- Package NDCs
69097-341-35- Official label
- DailyMed (National Library of Medicine), updated Apr 10, 2020
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