Theratears Extra Solution/ Drops
FDA Recall NDC 58790-010
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Theratears Extra (NDC 58790-010). A significant event, classified as Class II, was initiated on Sep 08, 2021 by Medtech Products Inc. The reported reason for this action was: "Lack of Assurance of Sterility"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility
Sep 08, 2021
Mar 30, 2022
62,331 box
Recall Profile & Regulatory Data
Event ID
89836
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Akorn, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within theUSA
Termination Date
Sep 28, 2023
Product Description
TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30
Batch or Lot Expiration Information
Lot# : 913012, 913013, 913014, Exp. Date 1/31/2023
Affected Packages Involved in this Recall
58790-010-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
