FDA Drug recall D-0770-2022
Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Ph…
- FDA Drug
- Class III
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class III recall of Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Ph… by Sun Pharmaceutical Industries, citing subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0770-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-04-01 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-506-96
Reason
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Identifiers
| ndc | 47335-506-96 |
|---|---|
| ndc | 47335-507-97 |
| code_info | Lot: 10014, 10016, Exp 08/2022 |
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-0770-2022%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.