Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine
Summary
The FDA issued a Class II for Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophth by Teva Pharmaceuticals USA Inc. Reason: Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity..
Details
Source
Drug Recall
External ID
D-0469-2023
Action Date
2023-03-22
Status
Terminated
Category
drug
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/Code Info: Lot #114349, Exp. 05/2023; 117396, Exp. 09/2023; 120128, Exp. 11/2023; 114371, Exp. 06/2023; 123781, Exp. 02/2024.
Quantity Affected: 715,632 bottles
Reason for Recall
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Distribution
Nationwide in the U.S.A.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-23
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 55 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Teva Pharmaceuticals USA Inc has 50 FDA actions in our database, including 50 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teva Pharmaceuticals USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA Inc have FDA actions?
Teva Pharmaceuticals USA Inc has 50 FDA actions in our database, including 50 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0469-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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