Recalls / Class II
Class IID-0469-2023
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.
- Affected lot / code info
- Lot #114349, Exp. 05/2023; 117396, Exp. 09/2023; 120128, Exp. 11/2023; 114371, Exp. 06/2023; 123781, Exp. 02/2024.
Why it was recalled
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Recalling firm
- Firm
- Teva Pharmaceuticals USA Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 715,632 bottles
- Distribution pattern
- Nationwide in the U.S.A.
Timeline
- Recall initiated
- 2023-02-23
- FDA classified
- 2023-03-20
- Posted by FDA
- 2023-03-22
- Terminated
- 2023-11-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0469-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.