Akorn recalls Neomycin and Polymyxin B Sulfates ophthalmic ointment due to CGMP deviations. This Rx-only product may not meet safety standards.
CGMP Deviations:
Akorn is recalling a specific ophthalmic ointment for potential quality issues. This recall affects prescription-only products that may not meet manufacturing safety standards.
The recall is due to CGMP (Current Good Manufacturing Practice) deviations during production. This means the product may not meet the required safety and quality standards for ophthalmic use.
Prescription users of this ophthalmic ointment, particularly those with eye conditions requiring medication. People who have the specific product with the listed NDC and lot number are most at risk.
Check for the product name 'Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.)'. The NDC number 17478-235-35 and lot number 1K64A (expiring 9/30/2023) are also key identifiers.
Identify the product by its NDC number (17478-235-35) and lot number (1K64A) if you have the specific ophthalmic ointment.
The recall states there were CGMP deviations, but the official notice does not specify if the product is safe to use.
The recall does not provide a specific remedy, so the official notice does not say what to do.
Look for the NDC number 17478-235-35 and lot number 1K64A on the product label.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0145-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0145-2023 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.
