# FDA recall D-0993-2019

> **Akorn, Inc.** · Class II · drug recall initiated 2019-02-22.

## Product

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

## Reason for recall

Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-0993-2019
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-02-22
- **Report date:** 2019-03-20
- **Termination date:** 2022-08-09

- **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-0993-2019

## Citation

> AI Analytics. FDA recall D-0993-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0993-2019. Source: US FDA. Licensed CC0.

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