Akorn recalls 5% Sodium Chloride Ophthalmic Ointment due to sterility testing failures. Products with lot numbers 9J58A or 9J58B may have turbidity affecting eye safety.
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Akorn is recalling certain 5% Sodium Chloride Ophthalmic Ointment tubes because sterility testing found turbidity. This could pose a risk to eye health if the ointment is not sterile.
Turbidity in the ointment means it may not be sterile, which could cause eye infections or irritation. The issue was found during sterility testing and affects products made with the same root cause.
People who own or use the recalled ointment tubes with lot numbers 9J58A or 9J58B are affected. Those with eye conditions may be at slightly higher risk due to potential contamination.
Check the tube for lot numbers 9J58A or 9J58B. The product is labeled as Sodium Chloride Ophthalmic Ointment USP 5% Sterile, Net Wt 3.5 g (1/8 oz).
Look for lot numbers 9J58A or 9J58B on the tube label.
The recall is due to potential sterility issues found in testing. If you have the recalled lot numbers, stop using it and contact Akorn for guidance.
Check the lot number on the tube. If it's 9J58A or 9J58B, stop using it and contact Akorn for instructions.
Look for lot numbers 9J58A or 9J58B on the tube label. The product is labeled as Sodium Chloride Ophthalmic Ointment USP 5% Sterile, Net Wt 3.5 g (1/8 oz).
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-1496-2022 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-1496-2022 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.
