# FDA recall D-0982-2022

> **Novartis Pharmaceuticals Corporation** · Class III · drug recall initiated 2022-05-10.

## Product

Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936.

## Reason for recall

Failed Impurities/Degradation Specifications.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0982-2022
- **Recalling firm:** Novartis Pharmaceuticals Corporation
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-05-10
- **Report date:** 2022-06-15
- **Termination date:** 2024-02-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0982-2022

## Citation

> AI Analytics. FDA recall D-0982-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0982-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*