NDC 62756-232
Loteprednol Etabonate 5 mg per 1 mL suspension/ drops
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited) | Halol Panchmahal, India | Makes it and tests it | No problems foundFeb 27, 2024 · 4 inspections |
Recalls
- Jul 5, 2023 · Class III · Sun Pharmaceutical Industries Inc
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Lots: Lot#: a) BAC0334A, Exp 06/2023; BAC0532A, Exp 11/2023 BAD0407A, Exp 08/2024 BAD0425A, Exp 08/2024; b) BAC0335A, Exp 06/2023, BAC0533A, Exp 10/2023, BAD0148A, Exp 03/2024, BAD0320A, Exp 07/2024
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
- suspension/ drops, ophthalmic
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA212450
- On the market since
- May 1, 2021
- Package NDCs
62756-232-5562756-232-5662756-232-90- Official label
- DailyMed (National Library of Medicine), updated Jul 13, 2026
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