FDA Drug recall D-0391-2021
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 2021-05-26
On 2021-05-26 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 and Presence of Particulates .
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0391-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-05-07 |
| Published | 2021-05-26 |
| 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 Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96
Reason
Subpotent and Presence of Particulates .
Identifiers
| ndc | 47335-506-96 |
|---|---|
| ndc | 47335-507-97 |
| code_info | Lot # 10009, exp. date 03/2022 10006, exp. date 01/2022 |
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-0391-2021%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.