# FDA recall D-0859-2020

> **Akorn, Inc.** · Class III · drug recall initiated 2020-02-21.

## Product

Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by:  Akorn, Inc., Lake Forest, IL 60045.  NDC 17478-622-35

## Reason for recall

Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.

## Distribution

Nationwide within United States and Puerto Rico

## Key facts

- **Recall number:** D-0859-2020
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-02-21
- **Report date:** 2020-03-04
- **Termination date:** 2022-07-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0859-2020

## Citation

> AI Analytics. FDA recall D-0859-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0859-2020. Source: US FDA. Licensed CC0.

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