Akorn recalls all 0.5% Levofloxacin Ophthalmic Solution 5mL bottles due to stability testing halted after company closure. No remedy provided in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all 0.5% Levofloxacin Ophthalmic Solution 5mL bottles because the manufacturer went out of business and could no longer conduct stability tests. This means the medication may not be safe for use as the quality assurance process was stopped.
The manufacturer went out of business and could no longer perform stability studies, which are necessary to ensure the medication remains safe and effective over time. Without these studies, there's uncertainty about whether the medication has degraded or become unsafe.
Prescription eye drop users who purchased the 0.5% Levofloxacin Ophthalmic Solution 5mL bottles from any source. Patients with eye infections requiring this medication are most at risk.
Check for 0.5% Levofloxacin Ophthalmic Solution 5mL bottles labeled with the manufacturer Akorn, Inc. from Lake Forest, IL. All product lots and National Drug Codes (NDCs) are affected.
Identify the product by checking the label for 0.5% Levofloxacin Ophthalmic Solution 5mL bottles manufactured by Akorn, Inc.
The official notice does not provide a remedy.
The manufacturer went out of business and could no longer continue stability studies, which are necessary to ensure the medication remains safe and effective.
Check for 0.5% Levofloxacin Ophthalmic Solution 5mL bottles labeled with the manufacturer Akorn, Inc. from Lake Forest, IL. All product lots and National Drug Codes (NDCs) are affected.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0820-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0820-2023 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
