Why it was recalled
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
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.
Lot numbers, UPCs & expiration codes
Lot #114349, Exp. 05/2023; 117396, Exp. 09/2023; 120128, Exp. 11/2023; 114371, Exp. 06/2023; 123781, Exp. 02/2024.
Where it was sold
Nationwide in the U.S.A.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0469-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 23, 2023
- FDA report date
- Mar 22, 2023
- Quantity
- 715,632 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0469-2023, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91757
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot #114349, Exp. 05/2023; 117396, Exp. 09/2023; 120128, Exp. 11/2023; 114371, Exp. 06/2023; 123781, Exp. 02/2024.
- Postal code
- 07054-1120
- Report date
- Mar 22, 2023
- Product type
- Drugs
- Recall number
- D-0469-2023
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Product quantity
- 715,632 bottles
- Termination date
- Nov 28, 2023
- Reason for recall
- Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the U.S.A.
- Recall initiation date
- Feb 23, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 20, 2023