Akorn recalls 0.5% Proparacaine Hydrochloride Ophthalmic Solution due to CGMP deviations. This prescription eye drop may have quality issues affecting safety.
CGMP Deviations:
Akorn is recalling prescription 0.5% Proparacaine Hydrochloride Ophthalmic Solution bottles that were manufactured with CGMP deviations. This recall means the product may have quality issues that could affect safety.
CGMP deviations refer to quality control issues during manufacturing that could affect the product's safety and effectiveness. These deviations may result in the eye drop being unsafe for medical use.
Prescription eye drop users who have the specific bottle with NDC 13985-611-15 and lot numbers 0L53A (expiring 10/31/2022) or 1J49A (expiring 8/31/2023).
Check for the NDC code 13985-611-15 on the bottle label. Look for lot numbers 0L53A (expiring 10/31/2022) or 1J49A (expiring 8/31/2023).
Identify the NDC code 13985-611-15 and lot numbers 0L53A or 1J49A on the bottle.
The recall states there were CGMP deviations, which may affect safety, but the official notice does not specify if the product is unsafe.
The official recall notice does not provide a remedy or instructions for action.
Check for NDC code 13985-611-15 and lot numbers 0L53A (expiring 10/31/2022) or 1J49A (expiring 8/31/2023).
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0154-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0154-2023 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.
