PlainRecalls
FDA Drug Moderate 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. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC 678112000708; NDC 67172-504-01.

Reported: March 22, 2023 Initiated: February 23, 2023 #D-0469-2023

Product 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.

Reason for Recall

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

Details

Units Affected
715,632 bottles
Distribution
Nationwide in the U.S.A.
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Teva Pharmaceuticals USA Inc. Units affected: 715,632 bottles.
Why was this product recalled?
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 22, 2023. Severity: Moderate. Recall number: D-0469-2023.