February 2023 FDA Recall Drug by Teva Pharmaceuticals Usa Inc
D-0469-2023 - Failed Impurities Specification

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa Inc on February 23, 2023 for the product Drug. The FDA reported the reason for recall as failed impurities specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0469-2023

Reason for Recall
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Initiated
02-23-2023
Reported
03-22-2023
Quantity
715,632 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91757
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the U.S.A.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-28-2023
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 114349, Exp. 05/2023; 117396, Exp. 09/2023; 120128, Exp. 11/2023; 114371, Exp. 06/2023; 123781, Exp. 02/2024.