Akorn recalls specific lots of Proparacaine Hydrochloride Ophthalmic Solution due to CGMP deviations. This medication is prescription-only and may pose safety risks if used improperly.
CGMP Deviations:
Akorn is recalling certain lots of prescription Proparacaine Hydrochloride Ophthalmic Solution. The recall is due to manufacturing quality control issues that could affect product safety.
The recall is for CGMP (Current Good Manufacturing Practice) deviations, which means the product was made under conditions that don't meet safety and quality standards. This could lead to potential safety issues if the medication is used as intended.
Prescription patients using the recalled lots of Proparacaine Hydrochloride Ophthalmic Solution. Those with the specific lot numbers listed in the recall are most at risk.
Check the product label for the lot numbers: 0L42A, 0L50A (expiring 10/31/2022), 1C64A, 1C76A (expiring 2/28/2023), 1G53A (expiring 6/30/2023), or 1J26A, 1J25A, 1J48A, 1J54A (expiring 8/31/2023). The product is a prescription-only ophthalmic solution.
Look for the lot numbers listed in the recall: 0L42A, 0L50A, 1C64A, 1C76A, 1G53A, 1J26A, 1J25A, 1J48A, 1J54A.
The recall is due to CGMP deviations, which means the product may not meet safety standards. Do not use the recalled lots until you contact the manufacturer.
Check the product label for the specific lot numbers: 0L42A, 0L50A (expiring 10/31/2022), 1C64A, 1C76A (expiring 2/28/2023), 1G53A (expiring 6/30/2023), or 1J26A, 1J25A, 1J48A, 1J54A (expiring 8/31/2023).
The recall does not specify a remedy, so contact Akorn directly for guidance on what to do with the product.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0153-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0153-2023 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.
