Akorn recalls 0.1% ophthalmic solution bottles due to inability to conduct stability studies after company closure. No remedy provided; affected products include all lots and NDCs.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all 5mL ophthalmic solution bottles (0.1% olopatinadine) because the manufacturer went out of business and can no longer test product stability. This means the medication may not be safe for use as the company can no longer ensure it remains effective and stable.
The manufacturer went out of business and can no longer perform stability testing, which means the medication's effectiveness and safety over time cannot be guaranteed. Without ongoing testing, there is a risk that the product may degrade or become unsafe for use.
Prescription eye drop users who own any 5mL bottle of olopatadine HCl ophthalmic solution. Those most at risk are individuals who have been prescribed this medication and are using it regularly.
Check for 5mL bottles labeled 'Olopatadine HCl Ophthalmic Solution, USP, 0.1%'. All lots and National Drug Codes (NDCs) are affected. This product is only available by prescription.
Identify if you have the 5mL ophthalmic solution bottles with the product name and strength listed.
The manufacturer went out of business and can no longer conduct stability studies to ensure the product remains safe and effective.
No remedy is provided in the official recall notice.
All 5mL bottles of olopatadine HCl ophthalmic solution (0.1%) are affected, including all lots and National Drug Codes (NDCs).
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0833-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0833-2023 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.
