# FDA recall D-0148-2023

> **Akorn, Inc.** · Class II · drug recall initiated 2022-10-13.

## Product

Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by:  Akorn, Inc., Lake Forest, IL 60045.  NDC:  17478-308-05

## Reason for recall

CGMP Deviations:

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0148-2023
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2022-10-13
- **Report date:** 2023-01-25

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0148-2023

## Citation

> AI Analytics. FDA recall D-0148-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0148-2023. Source: US FDA. Licensed CC0.

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