Cequa — Class III drug recall D-0770-2022
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2022-04-13, distributed nationwide. Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the
| Recall number | D-0770-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2022-04-01 |
| Classified | 2022-04-14 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2023-07-21 |
| Distributed | Nationwide (US) |
| Quantity | 73,030 boxes |
| Reason classes | potency, specification failure |
| NDC | 47335-0506, 47335-0506-96, 47335-0507, 47335-0507-97 |
| Lot numbers | 10014, 10016 |
| Expiration dates | 2022-08 |
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 for recall
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0770-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.