Akorn recalls 0.5% Tropic: Stability studies halted due to company bankruptcy. All 15mL bottles with NDCs are affected. No remedy provided.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all 15mL bottles of Tropicamide Ophthalmic Solution 0.5% (Rx only) because the manufacturer went out of business and can no longer perform stability testing. This means the medication may not be safe for use as the company can no longer ensure its quality.
The manufacturer went out of business and can no longer conduct stability studies. This means the medication's safety and effectiveness cannot be confirmed, potentially leading to adverse effects if used.
Prescription users of Tropicamide Ophthalmic Solution 0.5% 15mL bottles. Patients who have this medication and are under a doctor's care are most at risk.
Check for 15mL bottles labeled Tropicamide Ophthalmic Solution 0.5% (Rx only). All NDCs and lots are affected. The product was distributed by Akorn Operating Company LLC in Gurnee, IL.
Identify the product by checking the NDC number and lot number on the bottle.
The manufacturer went out of business and can no longer continue stability studies, so the safety of the product cannot be confirmed.
No remedy is provided in the recall notice.
All 15mL bottles of Tropicamide Ophthalmic Solution 0.5% (Rx only) with NDC numbers are affected.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0853-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0853-2023 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.
