# FDA recall D-0414-2019

> **Akorn, Inc.** · Class II · drug recall initiated 2018-10-08.

## Product

Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10

## Reason for recall

Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-0414-2019
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-10-08
- **Report date:** 2019-02-06
- **Termination date:** 2022-06-15

- **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-0414-2019

## Citation

> AI Analytics. FDA recall D-0414-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0414-2019. Source: US FDA. Licensed CC0.

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