Status
Terminated
Drug Enforcement D-0469-2023
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Classification
Class II
Report Date
March 22, 2023
Termination Date
November 28, 2023
Product Information
- 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.
- Product quantity
- 715,632 bottles
- Reason for recall
- Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the U.S.A.
Location & Firm
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Address
-
400 Interpace Pkwy Bldg A, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0469-2023
- Event ID
- 91757
- Recall initiation date
- February 23, 2023
- Center classification date
- March 20, 2023
- Code info
- Lot #114349, Exp. 05/2023; 117396, Exp. 09/2023; 120128, Exp. 11/2023; 114371, Exp. 06/2023; 123781, Exp. 02/2024.
- More code info
- —