Drug recall
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL…
FDA recall event 93006 · Class III · SUN PHARMACEUTICAL INDUSTRIES INC
Key facts
| Event ID | 93006 |
|---|---|
| Recall numbers | D-1172-2023 |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Subpotent: Out of Specification result observed for low assay |
| Initiation date | Sep 7, 2023 |
| Report date | Sep 27, 2023 |
| Termination date | Feb 13, 2024 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3013472760 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: