Akorn recalls levofloxacin oral solution bottles due to CGMP deviations after firm went out of business. All sizes and lots affected. No remedy provided.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling levofloxacin oral solution bottles (100mL, 200mL, 480mL) because the manufacturer went out of business and could no longer conduct stability studies. This means the product's safety and effectiveness cannot be confirmed.
The manufacturer went out of business and stopped stability testing, meaning the product's safety and effectiveness cannot be confirmed. This could lead to ineffective treatment or adverse reactions if used without proper quality assurance.
Prescription patients who have received levofloxacin oral solution from Akorn. Those with the product in their medicine cabinet or prescription are most at risk.
Check for Akorn, Inc. branded levofloxacin oral solution bottles labeled 25 mg/mL in 100mL, 200mL, or 480mL sizes. All lots and all NDC numbers are affected.
Identify if you have Akorn levofloxacin oral solution bottles in 100mL, 200mL, or 480mL sizes with 25 mg/mL concentration.
The manufacturer went out of business and could no longer continue stability studies, so the product's safety and effectiveness cannot be confirmed.
The recall notice states no remedy is provided.
All levofloxacin oral solution bottles from Akorn, Inc. in 100mL, 200mL, or 480mL sizes with 25 mg/mL concentration.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0819-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0819-2023 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.
