NDC 47335-507
Cequa 0.0009 mg per 1 mL solution/ drops
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Laboratoire Unither | Coutances, France | Makes it | Problems found, fixed voluntarilyOct 22, 2021 · 5 inspections |
| TAPI Czech Industries s.r.o | Opava, Czech Republic | Makes the active ingredient | Not inspected on record |
Recalls
- Sep 7, 2023 · Class III · Sun Pharmaceutical Industries Inc
Subpotent: Out of Specification result observed for low assay
Lots: Lot# 10026, Lot 10027, Exp. 09/2023. - Apr 1, 2022 · Class III · Sun Pharmaceutical Industries Inc
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Lots: Lot: 10014, 10016, Exp 08/2022 - May 7, 2021 · Class III · Sun Pharmaceutical Industries Inc
Subpotent and Presence of Particulates .
Lots: Lot # 10009, exp. date 03/2022 10006, exp. date 01/2022 - Feb 22, 2021 · Class III · Sun Pharmaceutical Industries Inc
Subpotent
Lots: Lot 10007, exp. date 01/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Cyclosporine: every company that makes it
- Form
- solution/ drops, ophthalmic; topical
- Strength
- 0.0009 mg per 1 mL
- Approval
- NDA NDA210913
- On the market since
- Aug 15, 2018
- Package NDCs
47335-507-97- Official label
- DailyMed (National Library of Medicine), updated Jun 15, 2026
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