FDAClass IIJanuary 25, 2023

Levofloxacin Ophthalmic Solution 0.5% recall: CGMP Deviations

Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10

Why was Levofloxacin Ophthalmic Solution 0.5% 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 # 1F43A, EXP 5/31/2/023

Product
Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
Recalling firm
Akorn, Inc.
Quantity
3108 bottles
Distribution
Nationwide in the USA
Recall date
January 25, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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