Akorn recalls all 8% Ciclopirox Topical Solution 6.6mL nail lacquer bottles due to stability problems after the manufacturer ceased operations. No remedy provided in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all 8% Ciclo:pirox topical solution nail lacquer bottles because the manufacturer went out of business and can no longer ensure product stability. This means the medication may degrade over time, potentially affecting safety and effectiveness.
The manufacturer went out of business and stopped conducting stability tests, meaning the product's safety and effectiveness could degrade over time. Without ongoing testing, there's no guarantee the medication remains stable or safe for use after the expiration date.
Prescription users who own any 6.6mL Ciclopirox nail lacquer bottles from Akorn. Those most at risk are individuals who rely on this medication for nail treatment and may not have noticed the product expired.
Check for 6.6mL bottles labeled 'Ciclopirox Topical Solution 8% (Nail Lacquer)' with prescription-only status. All products were distributed by Akorn Operating Company, LLC. in Gurnee, IL.
Identify if your bottle has the 6.6mL size and 'Ciclopirox Topical Solution 8% (Nail Lacquer)' label.
The manufacturer went out of business and could no longer continue stability studies, which means the product's safety and effectiveness could degrade over time.
No specific action is required beyond checking if you have the recalled product. The recall does not include a remedy to stop use or return the product.
The official notice does not specify a deadline for action.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0792-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0792-2023 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.
