Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Bausch & Lomb Incorporated | Tampa, FL, United States | Makes it, packages it and labels it | Serious problems, FDA actionMar 20, 2026 · 17 inspections, 3 with FDA action |
Recalls
- Jun 17, 2019 · Class III · Bausch & Lomb
Failed Stability Specifications: Out of specification for viscosity.
Lots: Lot #s: 282611; 283431; 283441; 283451, Exp. 10/2019; 282971; 282981; 283611; 283621; 283631, Exp. 11/2019.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Loteprednol: every company that makes it
- Form
- gel, ophthalmic
- Strength
- 5 mg per 1 g
- Approval
- NDA NDA202872
- On the market since
- Oct 12, 2012
- Package NDCs
24208-503-0724208-503-4824208-503-96- Official label
- DailyMed (National Library of Medicine), updated Oct 24, 2024
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