FDA-Drug2023-03-22Class II
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.
Teva Pharmaceuticals USA Inc
Hazard
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Sold states
Nationwide in the U.S.A.
Affected count
715,632 bottles
Manufactured in
400 Interpace Pkwy Bldg A, N/A, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0469-2023Don't want to check this manually?
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