Akorn recalls Betaxolol Ophthalmic Solution 0.5% (5mL) due to CGMP deviations. This prescription eye drop may have manufacturing issues affecting safety.
CGMP Deviations:
Akorn is recalling Betaxolol Ophthalmic Solution 0.5% (5mL) bottles because of manufacturing quality control issues. This recall affects prescription eye drops that may have safety risks due to improper production standards.
The recall is due to CGMP (Current Good Manufacturing Practice) deviations, which means the product was made under quality control standards that did not meet regulatory requirements. This could potentially lead to safety issues with the medication, though the exact risk is not specified in the recall notice.
Prescription eye drop users who have the specific Betaxolol Ophthalmic Solution 0.5% (5mL) bottles with NDC 17478-705-10 and lot 1A08A (expired 12/31/2022) are affected. People with eye conditions requiring this medication are most at risk.
Check for the product name 'Betaxolol Ophthalmic Solution, USP 0.5%' (5mL bottles), NDC code 17478-705-10, and lot number 1A08A (expired 12/31/2022). This prescription eye drop is only available with a doctor's prescription.
Verify the NDC code 17478-705-10 and lot number 1A08A on the bottle label to confirm if it's affected.
The recall states there were CGMP deviations, but does not specify if the product is unsafe. The manufacturer has not provided details on the exact risk.
The recall record does not mention any remedy or replacement options.
The recall record does not specify a remedy, so you should contact the manufacturer or your healthcare provider for guidance.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0135-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0135-2023 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.
