# FDA recall D-0469-2023

> **Teva Pharmaceuticals USA Inc** · Class II · drug recall initiated 2023-02-23.

## Product

Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC 678112000708; NDC 67172-504-01.

## Reason for recall

Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.

## Distribution

Nationwide in the U.S.A.

## Key facts

- **Recall number:** D-0469-2023
- **Recalling firm:** Teva Pharmaceuticals USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-02-23
- **Report date:** 2023-03-22
- **Termination date:** 2023-11-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0469-2023

## Citation

> AI Analytics. FDA recall D-0469-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0469-2023. Source: US FDA. Licensed CC0.

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