# FDA recall D-1317-2022

> **Mckesson Medical-Surgical Inc. Corporate Office** · Class II · drug recall initiated 2022-06-29.

## Product

Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05.

## Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-1317-2022
- **Recalling firm:** Mckesson Medical-Surgical Inc. Corporate Office
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-06-29
- **Report date:** 2022-08-17
- **Termination date:** 2024-02-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richmond, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1317-2022

## Citation

> AI Analytics. FDA recall D-1317-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1317-2022. Source: US FDA. Licensed CC0.

---

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