# FDA recall D-1496-2022

> **Akorn, Inc.** · Class II · drug recall initiated 2022-08-31.

## Product

Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35

## Reason for recall

cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.

## Distribution

USA nationwide

## Key facts

- **Recall number:** D-1496-2022
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-08-31
- **Report date:** 2022-09-14
- **Termination date:** 2024-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gurnee, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1496-2022

## Citation

> AI Analytics. FDA recall D-1496-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1496-2022. Source: US FDA. Licensed CC0.

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