CYCLOSPORINE Recall D-0770-2022
Description: 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
CYCLOSPORINE Recall D-0770-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0770-2022 |
| Event ID | 89917 |
| Brand | CEQUA |
| Generic Name | CYCLOSPORINE |
| Manufacturer | CYCLOSPORINE |
| Original Package? | 1 |
| Active Substance | CYCLOSPORINE |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA. |
| Quantity | 73,030 boxes |
| Recall Reason | Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter. |
| Drug Classification | Class III |
| Drug Code Info | 20220413 |
| Product NDC | 47335-506 47335-507 |
| Product NUI | N0000175457 N0000175458 N0000182141 |
| Pharma Class (EPC) | Calcineurin Inhibitor Immunosuppressant [EPC] |
| Recall Initiation Date | 20220401 |
| Report Date | 20220413 |
| Classification Date | 20220414 |
| Address | 2 Independence Way Princeton, NJ 08540-6620 United States |
| Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 83HN0GTJ6D |
| Drug Application Number | NDA210913 |
| Structured Product Labeling (SPL ID) | be559875-7ddd-4045-b05f-f706d037cd1a |
| Structured Product Labeling (SPL Set ID) | 48c3d8a3-4289-4b52-9189-58b48596095c |
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