Key Takeaway

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. Tar by Teva Pharmaceuticals USA, Inc. was recalled on February 23, 2023. The hazard: Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.

FDA Drug Class II Terminated

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. Tar

Recalled: February 23, 2023 ~715,632 bottles units affected D-0469-2023

Description

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.

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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. Tar

Drugs

Company Information

Teva Pharmaceuticals USA, Inc.

Sellersville, PA, United States

View all 69 recalls by Teva Pharmaceuticals USA, Inc. →

Distribution

Nationwide in the U.S.A.

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Frequently Asked Questions

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