Akorn recalls 5% Sodium Chloride Ophthalmic Ointment tubes due to inability to conduct stability studies after firm went out of business. No remedy provided.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all 5% Sodium Chloride Ophthalmic Ointment tubes (3.5g) because the manufacturer went out of business and can no longer ensure product stability. This means the ointment may not be safe for use as it could degrade over time.
The manufacturer went out of business and could no longer perform stability testing. This means the ointment's effectiveness and safety over time cannot be confirmed, though it does not pose an immediate risk of serious injury.
People who own or use the recalled ointment tubes are affected. Those with eye conditions requiring regular ointment use may be at slightly higher risk due to potential degradation.
Check for 5% Sodium Chloride Ophthalmic Ointment, USP, 3.5g tubes with NDC numbers from the manufacturer. All lots and all products are affected.
Identify if you have the recalled ointment tubes by checking the NDC numbers and product description.
The official recall notice does not provide any remedy.
The manufacturer went out of business and could no longer continue stability studies.
Check for 5% Sodium Chloride Ophthalmic Ointment, USP, 3.5g tubes with NDC numbers from the manufacturer.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0844-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0844-2023 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.
