D-0469-2023 Class II Terminated
FDA drug recall D-0469-2023 was initiated by Teva Pharmaceuticals USA Inc on February 23, 2023 and is designated Class II. Reason for recall: Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity. The recall status is terminated (terminated November 28, 2023). Affected quantity: 715,632 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 22, 2023
- Initiation Date
- February 23, 2023
- Termination Date
- November 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 715,632 bottles
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.
Distribution Pattern
Nationwide in the U.S.A.
Code Information
Lot #114349, Exp. 05/2023; 117396, Exp. 09/2023; 120128, Exp. 11/2023; 114371, Exp. 06/2023; 123781, Exp. 02/2024.