FDA Drug recall D-1172-2023
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured…
- FDA Drug
- Class III
- terminated
- Published 2023-09-27
On 2023-09-27 the FDA classified a Class III recall of Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured… by Sun Pharmaceutical Industries, citing subpotent: Out of Specification result observed for low assay.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1172-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-09-07 |
| Published | 2023-09-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96
Reason
Subpotent: Out of Specification result observed for low assay
Identifiers
| ndc | 47335-506-96 |
|---|---|
| ndc | 47335-507-97 |
| code_info | Lot# 10026, Lot 10027, Exp. 09/2023. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1172-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.