Akorn recalls 0.5% Proparacaine HCl Ophthalmic Solution 15mL bottles (Rx only) because the manufacturer went out of business and can't continue stability testing.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling 0.5% Propar: 15mL eye drop bottles that require a prescription. The recall happens because the manufacturer went out of business and can't safely test the product's stability anymore.
The manufacturer went out of business and can no longer perform stability studies. This means the product's safety and effectiveness can't be confirmed over time. Without ongoing testing, there's a risk the product might not work as intended or could be unsafe.
People with a prescription for these eye drops are affected. Those who have the product and need it for medical reasons are at risk.
Check for 15mL bottles labeled 'Proparacaine HCl Ophthalmic Solution, USP 0.5%'. The product is prescription-only and distributed by Akorn Operating Company LLC in Gurnee, IL. All National Drug Codes (NDCs) and all lots are included in the recall.
Look for the product name, size (15mL), and prescription status on the bottle.
The manufacturer went out of business and can no longer continue stability studies, so the product's safety and effectiveness can't be confirmed.
The recall doesn't specify a stop-use instruction, so you can continue using it if you have a prescription but should check with your doctor.
Check for 15mL bottles labeled 'Proparacaine HCl Ophthalmic Solution, USP 0.5%' that require a prescription.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0839-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0839-2023 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.
