PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 30, 2022 Initiated: September 8, 2021 #D-0717-2022

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

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Akorn, Inc.
Units Affected
62,331 box
Distribution
Nationwide within theUSA
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Akorn, Inc.. Units affected: 62,331 box.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on March 30, 2022. Severity: Moderate. Recall number: D-0717-2022.