# FDA recall D-0770-2022

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class III · drug recall initiated 2022-04-01.

## 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.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0770-2022
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-04-01
- **Report date:** 2022-04-13
- **Termination date:** 2023-07-21

- **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-0770-2022

## Citation

> AI Analytics. FDA recall D-0770-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0770-2022. Source: US FDA. Licensed CC0.

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