# FDA recall D-0717-2022

> **Akorn, Inc.** · Class II · drug recall initiated 2021-09-08.

## Product

TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Nationwide within theUSA

## Key facts

- **Recall number:** D-0717-2022
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-09-08
- **Report date:** 2022-03-30
- **Termination date:** 2023-09-28

- **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-0717-2022

## Citation

> AI Analytics. FDA recall D-0717-2022. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/D-0717-2022. Source: US FDA. Licensed CC0.

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