# FDA recall D-1172-2023

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class III · drug recall initiated 2023-09-07.

## 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  NDC 47335-506-96

## Reason for recall

Subpotent: Out of Specification result observed for low assay

## Distribution

Nationwide wide in the USA

## Key facts

- **Recall number:** D-1172-2023
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-09-07
- **Report date:** 2023-09-27
- **Termination date:** 2024-02-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1172-2023

## Citation

> AI Analytics. FDA recall D-1172-2023. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/D-1172-2023. Source: US FDA. Licensed CC0.

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