# FDA recall D-0577-2018

> **Akorn, Inc.** · Class III · drug recall initiated 2018-02-21.

## Product

Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.  NDC: 17478-215-05

## Reason for recall

Failed Stability Specification: OOS low viscosity results discovered during retain testing.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0577-2018
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-02-21
- **Report date:** 2018-03-14
- **Termination date:** 2020-08-31

- **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-0577-2018

## Citation

> AI Analytics. FDA recall D-0577-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0577-2018. Source: US FDA. Licensed CC0.

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