Akorn recalls Timolol Maleate Ophthalmic Solution 0.5% in various bottle sizes due to inability to perform 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 Timolol Maleate Ophthalmic Solution 0.5% in 2.5mL, 5mL, 10mL, and 15mL bottles because the manufacturer went out of business and can no longer conduct stability testing. This means the medication may not be safe for long-term use.
The manufacturer went out of business and can no longer perform stability studies, which means the medication's safety and effectiveness over time cannot be confirmed. This could lead to potential issues with the medication's performance.
People with prescriptions for Timolol Maleate Ophthalmic Solution 0.5% in 2.5mL, 5mL, 10mL, or 15mL bottles. Those who have the medication and need it for eye conditions are most at risk.
Check for Timolol Maleate Ophthalmic Solution 0.5% in 2.5mL, 5mL, 10mL, or 15mL bottles. The product is prescription-only and manufactured by Akorn, Inc. in Lake Forest, IL.
Identify if your medication is Timolol Maleate Ophthalmic Solution 0.5% in 2.5mL, 5mL, 10mL, or 15mL bottles.
The manufacturer went out of business and can no longer perform stability studies, so the safety and effectiveness of the medication over time cannot be confirmed.
Check if you have the medication in the recalled bottle sizes. If so, contact your doctor or pharmacist for guidance.
The recall 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-0849-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0849-2023 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.
