Drug recall
Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%…
FDA recall event 91757 · Class II · Teva Pharmaceuticals USA Inc
Key facts
| Event ID | 91757 |
|---|---|
| Recall numbers | D-0469-2023 |
| Recalling firm | Teva Pharmaceuticals USA Inc |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity. |
| Initiation date | Feb 23, 2023 |
| Report date | Mar 22, 2023 |
| Termination date | Nov 28, 2023 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 3003092769 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: