Akorn recalls Olopatadine HCl eye drops due to manufacturing quality issues. This Rx-only medication may have safety concerns from CGMP deviations.
CGMP Deviations:
Akorn is recalling Olopatadine HCl Ophthalmic Solution (0.1%, 5mL) because of manufacturing quality issues. This recall affects prescription eye drops that could pose safety risks due to deviations in quality control processes.
The recall is for CGMP (Current Good Manufacturing Practice) deviations, which means the product may not meet quality standards. This could potentially lead to safety issues with the medication, though the exact risk isn't specified in the recall notice.
Prescription eye drop users who received this specific Olopatadine HCl solution from Akorn. People with eye conditions requiring this medication are most at risk.
Check for the product name 'Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle' with NDC 17478-105-05 and lot number 1B41A expiring 1/31/2023. This is a prescription-only medication.
Verify the product name, NDC number 17478-105-05, and lot number 1B41A expiring 1/31/2023 to confirm if it's affected.
The recall states there were CGMP deviations, but the official notice doesn't specify if the product is safe or unsafe.
Check for the product name 'Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle' with NDC 17478-105-05 and lot number 1B41A expiring 1/31/2023.
The recall does not specify a remedy, so the official notice doesn't say what to do next.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0147-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0147-2023 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.
