FDA recall D-0469-2023

Teva Pharmaceuticals USA Inc · Class II · drug

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

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

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