Akorn recalls 15mL 5% Sodium Chloride Ophthalmic Solution bottles due to inability to conduct stability studies after firm went out of business. All products are affected.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all 15mL bottles of 5% Sodium Chloride Ophthalmic Solution because the company went out of business and can no longer ensure the product's stability. This means the solution may not be safe for use as it could degrade over time.
The company went out of business and can no longer perform stability testing. This means the product's safety and effectiveness over time cannot be guaranteed. Without stability studies, the solution might degrade and cause eye irritation or infection.
People who have the 15mL bottles of 5% Sodium Chloride Ophthalmic Solution from Akorn. Those with eye irrigation needs are most at risk if the solution degrades.
Check for 15mL bottles labeled 'Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL'. All products are affected regardless of lot number or distribution date.
Look for the product name and size on the bottle label to confirm it's the recalled item.
Reach out to Akorn for specific guidance on handling the product.
The recall is due to the company going out of business and not being able to conduct stability studies. The product may degrade over time and cause eye irritation or infection.
All 15mL bottles of 5% Sodium Chloride Ophthalmic Solution from Akorn are affected. Check the label for the product name and size.
The official recall does not specify a specific action. Contact Akorn for guidance on handling 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-0845-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0845-2023 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.
