Akorn recalls 0.5% erythromycin ophthalmic ointment tubes with CGMP deviations. These prescription eye drops may have manufacturing issues. Check NDC and expiration dates for affected lots.
CGMP Deviations:
Akorn is recalling prescription erythromycin ophthalmic ointment tubes due to manufacturing deviations. This recall affects specific lots with expiration dates up to April 2024. The issue could lead to product quality problems, though serious injury risks are not specified.
The recall is for CGMP (Current Good Manufacturing Practice) deviations, which means the product may not meet quality standards during production. This could affect the medication's effectiveness or safety, but the record does not specify a risk of serious injury.
Prescription eye drop users who have the specific lot numbers and expiration dates listed in the recall. People with eye conditions requiring this medication are most at risk.
Check the NDC code (17478-070-35) and expiration date on the tube. Affected lots include 0L58A (exp 10/31/2022), 1B21A (exp 1/31/2023), and others listed with specific expiration dates up to April 2024.
Look for the NDC code 17478-070-35 and expiration date on the tube. Affected lots have specific expiration dates listed in the recall.
The recall is for manufacturing deviations, but the product is still safe to use if it's not in the affected lots. Check the NDC and expiration date to confirm.
Check the NDC code (17478-070-35) and expiration date on the tube. Affected lots include specific combinations like 0L58A (exp 10/31/2022) and others listed in the recall.
The recall does not specify a remedy, so contact your doctor or pharmacist for advice on whether to use the product.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0138-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0138-2023 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.
