Akorn recalls 5% Sodium Chloride Ophthalmic Ointment due to CGMP deviations. Affected lots from 2023-2024 may pose quality risks. Consumers should check NDC and lot numbers for affected products.
CGMP Deviations:
Akorn is recalling 5% Sodium Chloride Ophthalmic Ointment tubes that were manufactured with CGMP deviations. This recall is due to potential quality issues that could affect the product's safety and effectiveness.
CGMP deviations refer to quality control failures during manufacturing that could impact the ointment's safety and effectiveness. These deviations may lead to product contamination or improper concentration, but the specific risk is not detailed in the recall notice.
People who have the affected ointment tubes (NDC 17478-622-35) from the listed lots and expiration dates. Eye care users are most at risk if they have the recalled product.
Check the NDC number 17478-622-35 on the tube. Look for specific lot numbers: 0F69A (exp 5/31/2023), 0G92B (exp 6/30/2023), and other listed lots with their expiration dates.
Identify the NDC number 17478-622-35 and lot numbers from the list provided in the recall notice.
The recall is due to CGMP deviations during manufacturing, which could affect the product's safety and effectiveness, but the specific risk is not detailed in the notice.
Check the NDC number 17478-622-35 and lot numbers listed: 0F69A (exp 5/31/2023), 0G92B (exp 6/30/2023), and other specific lots with their expiration dates.
The recall notice does not specify a remedy, so contact Akorn directly for guidance on next steps.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0155-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0155-2023 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.
