Akorn recalls Levofloxacin Ophthalmic Solution 0.5% (5mL) due to CGMP deviations. This prescription eye drop may not meet quality standards. Contact Akorn for details.
CGMP Deviations:
Akorn is recalling prescription levofloxacin eye drops because of manufacturing quality issues. This could affect the safety and effectiveness of the medication.
CGMP deviations mean the manufacturing process did not meet quality standards. This could lead to the medication being ineffective or unsafe for use in the eye. However, the exact risk level is not specified in the recall notice.
Prescription eye drop users who have the specific 0.5% levofloxacin solution in 5mL bottles with NDC 17478-106-10 and lot number 1F43A. People with eye conditions requiring this medication are most at risk.
Check for the product name 'Levofloxacin Ophthalmic Solution 0.5%', 5mL bottles, NDC code 17478-106-10, and lot number 1F43A. This product was manufactured by Akorn in Lake Forest, Illinois.
Verify the NDC code 17478-106-10 and lot number 1F43A on the bottle label.
The recall states there were CGMP deviations, but the exact safety impact is not specified. Consult a healthcare provider for advice.
Look for the NDC code 17478-106-10 and lot number 1F43A on the bottle label.
The recall does not specify a remedy, so contact Akorn directly for guidance.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0142-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0142-2023 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.
