Could cause temporary or reversible harm; serious harm is unlikely.
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
| Distributed by / for | Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company |
| NDC | 67172-504-01 |
| Full product label | 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. |
| Recalling firm | Teva Pharmaceuticals USA Inc |
| Distribution | Nationwide in the U.S.A. |
| Quantity | 715,632 bottles |
| Recall initiated | 2023-02-23 |
| Report date | 2023-03-22 |
| Recall completed | 2023-11-28 |
| Recall number | D-0469-2023 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Parsippany NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗