TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn C
Summary
The FDA issued a Class II for TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 S by Akorn, Inc.. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0717-2022
Action Date
2022-03-30
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #: 913012, 913013, 913014, Exp. Date 1/31/2023
Quantity Affected: 62,331 box
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide within theUSA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-08
Company
Lake Forest, IL
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 78 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Akorn, Inc. has 130 FDA actions in our database, including 130 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 (Akorn, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Akorn, Inc. have FDA actions?
Akorn, Inc. has 130 FDA actions in our database, including 130 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0717-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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