Akorn recalls 0.1% Tropic: Stability studies halted due to company bankruptcy. No remedy provided. Check NDCs and lots for affected products.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling 0.1% Tropicamide Ophthalmic Solution bottles because the manufacturer went out of business and stopped stability testing. This means the product's safety can't be confirmed, so it should not be used.
The manufacturer went out of business and stopped stability testing, which means the product's safety and effectiveness can't be verified. Without ongoing testing, there's no way to know if the medication could be harmful.
Prescription users who have the 15mL bottles with NDC numbers. People who received the product from Akorn's distribution in Illinois are most at risk.
Check the NDC numbers and production lots on the bottle. The product is a prescription-only 0.1% Tropicamide Ophthalmic Solution, 15mL bottles distributed by Akorn Operating Company LLC in Illinois.
Look for NDC numbers and production lots on the bottle label to confirm if it's affected.
The manufacturer went out of business and could no longer continue stability studies, so the product's safety can't be confirmed.
The recall doesn't provide a remedy, so check the NDC and lots to see if it's affected. Contact your doctor for advice.
The recall record doesn't 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-0864-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0864-2023 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.
