FDAClass IIJanuary 25, 2023

Artificial Tears Solution recall: CGMP Deviations

Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake…

Why was Artificial Tears Solution recalled?

CGMP Deviations:

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 0L44A, 0L52A, 0L51A, 0L77A, 0L75A, EXP 10/31/2022; 0M02A, 0M01A, EXP 11/30/2022; 1C81A, EXP 2/28/2023; 1D02A, 1D03A, EXP 3/31/2023; 1E10A, 1E08A, 1E23A, 1E26A, 1E25A, 1E27A, 1E33A, EXP 4/30/2023; 1F46A, EXP 5/31/2023; 1G49A, 1G50A, 1G67A, EXP 6/30/2023; 1H04A, 1H74A,1H76A, 1H05A, 1H07A, 1H15A, 1H13A, 1H95A, EXP 7/31/2023; 1J44A, 1J20A, EXP 8/31/2023;

Product
Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake…
Recalling firm
Akorn, Inc.
Quantity
967,075 bottles
Distribution
Nationwide in the USA
Recall date
January 25, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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