Akorn recalls all 0.5% Apraclonidine Ophthalmic Solution bottles due to inability to conduct stability studies after the company went out of business.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all 5mL and 10mL bottles of 0.5% Apracl:clonidine Ophthalmic Solution because the manufacturer went out of business and can no longer perform stability testing. This means the medication may not be safe for long-term use.
The manufacturer went out of business and can no longer conduct stability studies, which means the medication's effectiveness and safety over time cannot be confirmed. This could lead to reduced effectiveness or potential safety concerns if the product is used beyond its intended shelf life.
Prescription users of this eye drop medication are affected. Patients who have this product are most at risk due to potential stability issues.
Check for Akorn-branded 0.5% Apraclonidine Ophthalmic Solution in 5mL or 10mL bottles. All lots and all National Drug Codes (NDCs) are included in this recall.
Identify the product by checking the label for Akorn, 0.5% Apraclonidine Ophthalmic Solution, and bottle size (5mL or 10mL).
The recall indicates the manufacturer can no longer perform stability studies, so safety and effectiveness cannot be confirmed long-term. Consult your doctor for advice.
Check for Akorn-branded 0.5% Apraclonidine Ophthalmic Solution in 5mL or 10mL bottles. All lots and all National Drug Codes (NDCs) are included in this recall.
The recall does not specify a remedy, so contact your healthcare provider for guidance on whether to continue using 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-0784-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0784-2023 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.
